Medical Chronicle May 2022

MEDChronicle www.medicalacademic.co.za

The doctor's newspaper

MAY 2022

The NHI is a process, not an event

The National Health Insurance (NHI) Bill was recently in the news again when the National Department of Health was called to respond to some of the criticisms raised by stakeholders at the parliamentary public hearings on the NHI Bill.

By Nicky Belseck, medical journalist

P

RIOR TO THE Covid-19 pandemic, when it came to health in SA, there was no question that the NHI Bill was the main topic of discussion. While the Bill may not have made as many headlines over the last two years, the National Department of Health (NDoH) has still been working on implementing it as soon as possible.

Following President Cyril Ramaphosa’s announcement that the National State of Disaster had been lifted as from 5 April 2022 and with everyone getting used to the new ‘normal’, deputy director-general of the NHI, Dr Nicholas Crisp, gave an update on the state of NHI during a webinar hosted by The Institute of Health Risk Managers (IHRM) last month.

WHY DOES SA NEED NHI? “Health is not a tradeable commodity, it is a public good,” said Dr Crisp, and went on to explain that public goods are common resources that need to be supported by collective investment. Public goods are supported by all and accessible to all. “The reason they are public goods, rather than individual commodities, is we have decided that they are so fundamental to our wellbeing that they should not be entirely the province of private investment or market forces.

“With that as a point of departure, we recognise that SA is even more unequal than it was before, and it is now firmly and vastly more unequal than any other society in the world. We used to be competing with Brazil for this, but we are now firmly far ahead,” Dr Crisp said.

“We have an economy that does not equally benefit all citizens. In fact, 10% of the population owns more than 80% of the wealth. These inequities are shown in our income gap, our gender inequality, our healthcare, social classes, and a range of other places throughout our society. In healthcare, some individuals receive better and more professional care compared to others. The SA wealth gap has not only been unchanged but has deteriorated since apartheid. This is not something to be proud of,” he said.

“Our healthcare reflects our inequitable society. As a nation we spend 8.4% of our GDP on our health system but our outcomes are comparable with some of our neighbours including Mozambique in some instances, which is one of the poorest nations in the

Objective risk assessments in PAH optimise treatment

world. So, we are doing extremely poorly in terms of health outcomes, and that’s of serious concern to us. Part of the reason for that is that roughly half of our spend is in the public sector on the majority of the population, the other half is spent in the private sector on a minority of the population.

Two out of every three medical specialists work in the private sector.

“We have created a dual health system that entrenches and exacerbates inequity and poor health services in both public and private sectors. And we’ve reached a point where both the public sector and the private sector are in trouble. The public sector because it’s underserviced, and the private sector because it’s overserviced, and both are very duplicative and wasteful. “Our health system is failing everyone. Many poor people are denied care continued on page 3

continued on page 2

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NEWS

continued from page 1

when they need it. Meanwhile, many privileged people are given treatment they don’t need, some potentially harmful. And even wealthy people who insure their health with medical schemes end up paying in for costs not covered,” Dr Crisp said.

“The bottom line is what we have is not working for us. SA needs a health system that ensures that all people have access to the health services they need, when and where they need them, without financial hardships. This is what universal health coverage means. National Health Insurance means that we pay for this public good in advance with no cost to us as patients at the point of care when we need health services.

NHI NOT NEW “We’ve actually been trying to reform this healthcare system for a very long time, in fact we started in 1948 when Henry Gluckman was the Minister of Health he tried to implement the NHS, the same sort of form as the UK, and since then there have been more than 20 attempts to create a national health system in the country, both by the previous government and this government, but we’ve never managed to move beyond this.

Dr Crisp stressed the fact that there is room for improvement in both the public and private health sectors with a need for quality investment throughout the system. “To build a strong and reliable public health system, the implementation of NHI is supported by several parallel health system reforms and strengthening initiatives by using the six health systems building blocks described by the World Health Organization Framework, including leadership, financing, medical products and consumables, information technology, human resources for health, and service delivery.”

He further explained that the investment in public health sector quality improvement will continue through several integrated components to develop and improve the quality of services including the capacity of the health system to deliver service to communities. “The aim is to progressively build capacity and quality in both public and private sectors,” said Dr Crisp. “People believe the NHI will start on the first day of whatever, but that's not how it works. All these improvements will take time, hence the need for a staggered approach to accreditation to prevent collapsing of services while developing the quality. The point I’m making is that it’s a constant process and it happens on a journey, not an event on a particular day.”

STILL FIGURING IT OUT Dr Crisp also admitted that they hadn’t worked out how to do everything yet. Referring to the NHI Pilot Districts as examples he said they had learned many lessons. “For instance, the GP contracting in my opinion, has been a disaster, we have learned how not to contract GPs into the NHI rather than how to do it. We do want to contract GPs, but the way in which it was done in the pilot was not useful at all and we didn’t get value for money.”

FUNDING NHI “The bottom line is that in the end NHI is paid for by taxes, there’s no getting away from it, that’s how it works,” said Dr Crisp. “The

question is how much of that money is already in the system, but funded through different streams, and where is it?

“If we take the 8.4% of GDP, half of that is already paid for in tax allocated through the Division of Revenue Act or the MediumTerm Expenditure Framework – depending on whether you’re looking at one year or three years – and it’s already spent in the public service. So that’s about R260bn.

“Then we have R34bn which is already in the tax system that is refunded to people who get private medical schemes. Now that money, without changing the tax regiments at all, could slowly but surely be shifted into the public purse to purchase services from the NHI Fund.

“Then we have the subsidies which the public sector pays to its employees to purchase private healthcare. Now we don’t have the exact figure here, but we know that it’s more than R50bn,” said Dr Crisp. “We also pay huge sums of money into the Compensation Fund for Occupational Disease and Injury (COIDA) and the Road Accident Fund (RAF) and the health services that are provided through those funds are not going to be duplicated, they are only paid for by those funds, but they are duplicative, and they are quite expensive to deliver. So, rerouting those funds is also something that was raised in the hearings and is quite possible.

“What is left is not R200bn, or whatever the media keeps reporting, it’s substantially less and we will slowly but surely work out the numbers. We have done various models and not everybody agrees on what the numbers are, and there may be some double counting of some of these numbers in the process. But it’s definitely under R100bn.

“The question then becomes how do we raise the remaining money?” Dr Crisp asked. One of the things he said was to not spend money in the first place. “We need to stop the fraud and corruption, the R11bn in the private sector that is stolen every year and the billions that are stolen in the public sector every year. We need to put control measures in place to not waste that money. We need to cut down on the cost of administration. We know that in the private sector the cost of administration of the many funds, and that includes the practitioners’ costs to support them, the way they react to selling their services costs between 12%-15% of everything that is spent by medical schemes,” Dr Crisp stressed.

“What we’re working towards is having healthcare free at the point of care. Where we’ve paid for everything upfront in our tax collection mechanism,” said Dr Crisp. “Getting there will take some time, but we need to start, we need to begin the journey, next year, this year, whenever the Bill gets through the parliamentary process. Then, these various implementations need to be phased in. Starting with the public service, starting with primary healthcare, and then as we go through the budget cycles and systematically changing the way in which medical schemes work, looking at capping various things, harmonising PMBs with the primary healthcare benefits in the public sector, etc, many of the things that were listed in the Health Market Inquiry.

“It is a progressive process over several years and not an event,” concluded Dr Crisp.

May the force be with all of us Dear Reader May the force be with all of us during the start of the 5th wave, amid the flooding in KZN, load shedding and violence at hospitals. The National Health Insurance Bill was recently in the news again when the Department of Health was called to respond to some of the criticisms raised by stakeholders at the parliamentary public hearings on the NHI Bill. Find out more in this news article. On the technology front, robotic-assisted knee and hip replacements have been established in Pretoria. A team of orthopaedic surgeons at Netcare Pretoria East Hospital are using a robotic surgical system to expand options in hip and knee replacements. SA pulls together in KZN rescue effort. The apocalyptic floods that have ravaged KwaZulu-Natal have resulted in unspeakable loss, heartbreak, and displacement – the toll of which will be felt for a very long time.

Netcare brings our attention to the considerable effort on the ground and phenomenal involvement of a large rescue community of citizens and healthcare professionals alike.

The Healthcare Workers Care Network (HWCN) has found that 82% of the South African doctors, nurses and allied health professionals using its counselling services believe there is a stigma attached to healthcare workers asking for help with their own mental health.

Those who take care of others are more likely to suffer in silence than to seek help for their own symptoms of anxiety, depression, stress, and burnout.

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The HWCN network is a joint initiative of the South African Medical Association, the SA Depression and Anxiety Group, the SA Society of Psychiatrists, and the SA Society of Anaesthetists, supported by the Psychological Society of SA. We uncover their findings in this news article.

With a significant rise in coronavirus infections across SA, all signs point to the country entering a fifth wave. Epidemiologists predicted the fifth wave would hit around winter, which is also associated with flu season. This raises the urgency for everyone to get their annual flu shot as soon as possible.

Read more in news. One of the most significant concerns any healthcare practice faces is the possibility of fraud. Practitioners can become so focused on patient care that it is easy to neglect the proper management of financial and other risks. We expand on this in Limiting fraud in the healthcare practice. Dr Ilhaam Mohamed looks at the important aspect of quality of life in COPD. Over the last few years, there has been a continued global interest in pharmacological interventions, non-pharmacological measures and mental health programmes that may improve the quality of life in patients with COPD. Need to earn more CPD points? Don’t miss Getting rid of actinic keratosis. This article is a summary of an article available on www.medicalacademic.co.za. Take the quiz online and earn your CPD point immediately. In Strategies to manage VTE, Prof James Ker introduces us to haemodynamically stable venous thromboembolism. In the next issue of Medical Chronicle, he will examine strategies to manage the condition.

MAY 2022

CONTENTS

All content in Medical Chronicle is sourced independently and under no circumstances should articles be considered promotional unless specified. Please note that all advertising is intended for healthcare professionals only.

NEWS

The NHI is a process, not an event.............. 1 Robotic-assisted knee, hip replacements in Pretoria............................................................. 4 SA pulls together in KZN rescue effort.....6 Healthcare workers fear mental health stigma.....................................................................7 Flu vaccine vital ahead of 5th wave............8 Acino committed to expansion and localisation..........................................................10

CLINICAL

WEBINAR ANNOUNCEMENTS HIV in 2022: Paediatric update.....................5 An approach to HIV treatment failure......19 Is depression really a disease?.................30 PCT informing antimicrobial Stewardship? ...................................................32 COMPANY PROFILE Acino committed to expansion and location........................................................10 PRACTICE MANAGEMENT Limiting fraud in the healthcare practice................................................................12 OPHTHALMOLOGY Dry eyes cause tears..................................... 14 RESPIRATORY Quality of life in COPD.....................................15 DIABETES Type 1 diabetes: The burden of mealtime insulin dosing.....................................................16 IDegLira vs basal-bolus insulin in T2DM................................................................24 ONLINE CPD Getting rid of actinic keratosis...................18 INFECTIOUS DISEASES Healthcare providers are key to reducing cervical cancer..............................20 CARDIAC Strategies to manage VTE............................21 Objective risk assessments in PAH optimise treatmen..........................................26 ASTHMA Addition of LAMAs in asthma.....................22 BLEEDING DISORDERS How to distinguish AHA................................28 GASTROENTEROLOGY Gut microbiome’s role in diseases.............31 DIGITAL THERAPEUTICS App helps manage children's mental health................................................................... 33 ONCOLOGY The Evolution of genetics in breast cancer....................................................34 WEBINAR REPORT HIV 2022: An update......................................35 Exploring schizophrenia...............................36 A discussion on connective tissue disease...................................................37 OPINION How does motivational interviewing improve patient adherence.........................38 PLACEBO Beat the odds in severe brain injury........39

Happy reading MEDICAL CHRONICLE | May 2022 3

NEWS

Robotic-assisted knee,

hip replacements Orthopaedic surgeons have been trained in a high-tech precision option.

A

TEAM OF ORTHOPAEDIC surgeons at Netcare Pretoria East Hospital are expanding the options in hip and knee replacements for patients, using a robotic surgical system.

Orthopaedic surgeons Dr Wian van der Merwe and Dr Tiaan Stoffberg achieved full accreditation last year in the use of

this advanced technology, explained Pieter Louw, general manager of Netcare Pretoria East Hospital. To achieve accreditation, the specialists completed comprehensive training in Istanbul, Turkey, with the new SmartRobotics™ surgical system.

The Mako robotic system at Netcare Pretoria East Hospital is the first in Tshwane

and one of only a handful of these advanced systems in South Africa. Dr Van der Merwe performed the first robotic assisted hip and knee surgeries at the hospital in late November 2021, and many more patients have since chosen to have this option for their surgery.

“By the end of June, a further two

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REFERENCES: 1. Mesquita ET, Jorge AJL, Rabelo LM, Souza CV. Understanding hospitalization in patients with heart failure. Int J Cardiovasc Sci 2017;30(1):81-90. 2. Gheorghiade M, Luca LD, Fonarow GC, et al. Pathophysiologic targets in the early phase of acute heart failure syndro1mes. Am J Cardiol. 2005;96(6A): 1 IG-17G. a. 3. Ponikowski P, Voors AA, Anker SD, et al, for the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2016;37:2129-2200. 4. Hitzeroth J, Mpe M, Klug E, et al, on behalf of the Heart Failure Society of South Africa. 2020 Heart Failure Society of South Africa perspective on the 2016 European Society of Cardiology Chronic Heart Failure Guidelines. S Afr Med J 2020;110(9b):938-951. https://doi.org/10.7196/ SAMJ.2020.v110i8.14681 5. Vymada® Package insert, Novartis South Africa (Pty) Ltd; September 2017. 6. Solomon SD, Dobson J, Pocock S, et al. Influence of Nonfatal Hospitalization for Heart Failure on Subsequent Mortality in Patients With Chronic Heart Failure. Circulation. 2007;116:1482-1487. 7. Desai AS, Claggett BL, Packer M, et al. Influence of sacubitril/valsartan (LCZ696) on 30-day readmission after heart failure hospitalization. J Am Coll Cardiol. 2016;68(3):241-248. 8. McMurray JJV, Packer M, Desai AS, et al. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371(11):993-1004.

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orthopaedic surgeons practising at our hospital will complete the final leg of their accreditation in the use of the robotic assisted system. This will result in a total of four experienced orthopaedic surgeons offering this option to people requiring knee and hip replacements at our facility,” Louw says.

SURGICAL EXPERTISE MEETS ROBOTIC TECHNOLOGY Dr Van der Merwe explains that the Mako robotic system is designed to further improve surgical precision. The technology assists the surgeon in the planning of the procedure beforehand, and provides additional checks in real-time at each stage during the operation.

“Based on a CT scan of the patient’s knee, the system’s sophisticated software develops a 3D digital map of the knee, and calculates the optimal implant size, placement and alignment of the prosthetic knee joint to fit the patient’s specific anatomy. This data is then translated into a preoperative surgical plan,” Dr Van der Merwe says.

PRECISION AND EXTRA SAFEGUARDS “This offers an extra level of precision, adding to the surgeon’s own technique and experience. On the day of the procedure, the digital 3D map of the knee is carefully aligned to the patient’s actual knee in theatre, and the surgical plan is validated,” he explains.

“The dimensions needed for the procedure are set, and at these boundaries, cutting automatically stops, serving as an additional safeguard to preserve the surrounding soft tissues and healthy bone.

The resections achieved are extremely accurate to the surgical plan, being within a fraction of a millimetre,” Dr Van der Merwe says. As the surgeon guides the robotic arm system, it provides detailed visual, auditory, and tactile feedback.

“The robotic system cannot do anything without the surgeon. Rather, it helps keep the surgeon within the optimal dimensions to match the patient’s individual anatomy through the defined surgical plan.”

WHY ACCURACY MATTERS The stability of the knee joint, as well as the range of motion and comfort a person enjoys after a knee or hip replacement can be greatly influenced by the accuracy of the fit of the prosthetic joint for the specific patient.

“In addition, where there is minimal interference with the surrounding soft tissues, the post-operative recovery can often be quicker. This technological advance is a further tool we can use to help deliver advantages such as these for our patients,” Dr Van der Merwe says.

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Dr Leon J. Levin graduated MBBCh at the University of the Witwatersrand (Wits) in 1987. He did his internship at Hillbrow Hospital in Johannesburg in 1988 and a Medical Officer post in Paediatrics at Baragwanath Hospital in Soweto, Johannesburg from January to July 1989. After training at the Wits Group of Hospitals in Johannesburg in Paediatrics, he obtained his FCPaed(SA) in 1994. In 1995, he obtained his DTM&H at University of the Witwatersrand with distinction. From January 1995 to 28 Feb 1998, he was a Consultant Paediatrician at the Johannesburg Hospital. There he worked both in the Paediatric Pulmonology Department and was the head of a unit in the general Paediatric wards. In February 1996, he founded and ran the Paediatric HIV Clinic at the Johannesburg Hospital, From March 1998 to Feb 2008, he was in private paediatric practice in Benoni. He had a large HIV practice and was referred paediatric HIV patients from all over Africa. From 1 March 2008 to 30 September 2018, Dr Leon Levin was employed by Right to Care as Head of Paediatric HIV programmes and is currently Senior Technical Advisor in Paediatrics at Right to Care. Right to Care is a Johannesburg based nonprofit funded by USAID with a vision that all HIV-positive patients receive high quality treatment, care and support improving their quality of life and productivity. At Right to Care, Dr Levin’s primary role is to improve both the quality of paediatric care and the number of paediatric patients receiving antiretroviral

(ARV) Therapy at all the ARV sites that Right to Care is involved with. He was the Chairman of the Paediatric Subcommittee of the SA HIV Clinicians Society from 1999-2011. He was the convenor of the Southern African HIV Clinicians Society Paediatric Antiretroviral Guidelines published in November 2000, October 2002 and December 2005 and Co-convenor for the 2009 guidelines. He has also been on several SA DOH Paediatric and Adolescent ART Guidelines Committees. In 2013 Leon was invited onto the Paediatric 3rd line ART Committee for the SA DOH. He founded and runs the South African HIV Clinicians Society Paediatric Discussion Group which is an Internet based forum for paediatricians to discuss and learn about problems in paediatric patients with HIV. The mailing list is currently over 2000 and reaches all over Africa. He is advisor on Paediatric Antiretroviral Therapy to South African Medical Insurers and Managed Health Care Organizations. He has given numerous lectures to doctors, nurses, pharmacists and lay people on Paediatric and adult HIV Infection, Antiretroviral Therapy, Prevention of mother to Child transmission of HIV and HIV viral resistance workshops both in South Africa and in Botswana, Kenya, Lesotho, Malawi, Namibia, Nigeria, Mozambique, Rwanda, Swaziland, Uganda, Zambia and Zimbabwe. In addition he has given sever lectures and trainings on Covid-19. Dr Levin is married to Debbie, who is a social worker and they have three sons aged 23, 22 and 17 years.

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NEWS

SA pulls together in KZN rescue effort

The apocalyptic floods that have ravaged KwaZulu-Natal have resulted in unspeakable loss, heartbreak and displacement – the toll of which will be felt for a very long time.

C

OMMENTING ON THE tragedy that continues to unfold in KwaZuluNatal, Dr Richard Friedland, chief executive officer of Netcare said: “Like all fellow South Africans we are deeply

saddened by the human tragedy that has occurred, particularly when contemplating the immense impact this is having on the most vulnerable and poor, whose circumstances have been further worsened

by this catastrophic event. “Until now many may mistakenly have doubted the ability of South Africa to cope with a disaster of this magnitude and the scale of the rescue effort it would require. But the considerable

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effort on the ground has been phenomenal and the involvement of such a large rescue community has been nothing short of remarkable,” he asserts. Craig Grindell, managing director of Netcare 911, notes that resources were pulled together from across the country in a short space of time. “The resources represented various agencies and organisations such as the South African Defence Force, a number of provincial and private emergency medical services, the South African Police Service as well as many private search and rescue teams, among others. “Those on the ground say that this is one of the biggest rescue operations ever seen in South Africa – even greater than the rescue effort launched in January 1984, when Cyclone Domoina wrought havoc all the way from Mozambique to Swaziland. As many as 242 people succumbed during that tropical storm which brought the greatest deluge of rain in a century, with raging floodwaters leaving chaos and destruction in their wake,” he adds. Since Monday, 11 April, South Africa has pulled together one of the largest rescue efforts in recent memory locally, with the general consensus being that never before have we seen such a large team of rescuers working in tandem,” notes Grindell.

“On the aeromedical side, considerable expertise has come to the fore with military, SAPS, private medical helicopters and fixed wing aircraft having been deployed.

People from all walks of life, have joined the rescue effort. Support was also forthcoming from SAPS and private canine rescue teams from around the country as well as from experienced lifeguards and ordinary members of the public who have stepped forward to volunteer their services.

“Support initiatives by various NGOs such as Meals on Wheels, together with community involvement have been wholehearted and overwhelming and have provided tremendous relief aid, which includes anything from supplying refreshments for the rescuers to getting water, food and perishables to those who have been impacted by the flood. Amidst the tragic circumstances there has been a most incredible response countrywide,” says Grindell. In his address to the nation, President Cyril Ramaphosa called for ‘all hands on deck’ in the wake of the floods.

The men and women who left their families in their hundreds to join in the rescue and reconnaissance efforts pre-empted this call from the very outset. They are an inspiration and a reminder of all that is good and just. Sadly, their rescue mission has since become one of recovery in order to help provide closure to the loved ones of those who have been swept away by the floods.

NEWS

Healthcare workers fear

mental health stigma The Covid-19 pandemic has sparked a rise in mental health disorders worldwide, with healthcare workers on the frontline among the most affected, yet those who take care of others are more likely to suffer in silence than to seek help for their own symptoms of anxiety, depression, stress and burnout.

T

HE HEALTHCARE WORKERS Care Network (HWCN) has found that 82% of the South African doctors, nurses and allied health professionals using its counselling services believe there is a stigma attached to healthcare workers asking for help with their own mental health.

The network was set up early in the pandemic by a number of healthcare professional bodies*, anticipating the added stresses on healthcare workers and aiming to provide mental health support through a 24-hour helpline and online counselling, individual and group support, and training.

The services have reached almost 5 000 healthcare workers since April 2020, with an average of 175 calls to the helpline per month. A recent survey of the healthcare workers who used the services revealed high levels of reluctance to seek help for mental health challenges, and the reasons why.

For 80% of the healthcare workers, fear of judgement, by colleagues, managers and their profession, was the main reason for being unwilling or delaying finding support for their mental health concerns.

They fear being seen as incompetent, weak and unfit to do their jobs because of expectations that healthcare workers should be more resilient and better-equipped than the general public to deal with work stress and manage their own mental health.

Dr Antoinette Miric, SA Society of Psychiatrists (SASOP) representative on the HWCN convening body, said expectations that healthcare workers 'should be able to fix themselves' are unrealistic, placing health professionals

at risk, as well as their patients and the healthcare system as a whole.

“With a third of South Africans experiencing mental illness at some point in their lifetimes,2 and mental disorders the leading cause of disability, it is illogical to think that healthcare workers are exempt from mental health challenges.

“Despite this, the stigma attached to mental health is magnified in the healthcare sector amid intense pressure to deliver, to be resilient, super-human even, and fear of showing any sign of weakness,” she said.

She said that healthcare workers who avoid seeking help are at risk of selfmedicating, potentially leading to substance abuse and suicide.

“Healthcare workers are our first responders in a crisis like the pandemic, and they will be our guides and community allies on the road to recovery as the pandemic ends. We need to ensure that we support their mental health, wellbeing and resilience in order to ensure that our health system is strong, robust and resilient coming out of the pandemic and prepared for the next crisis,” Dr Miric said.

The respondents in the HWCN survey – a combination of doctors, nurses, support staff and allied professionals such as counsellors and social workers, in both the public and private sectors, spoke of expectations that they should be always in control and that their training should equip them to look after their own health.

Many commented that the perception of “How can you help others if you cannot help yourself?” made them reluctant to open

up to colleagues or managers that they are struggling with their mental health or to seek professional help.

The healthcare workers feared that a mental health issue would make them seem incompetent or weak, a burden on co-workers, and that their credibility and competence would be questioned.

They revealed a need to 'be seen as human beings behind the lab coat or uniform', with one respondent saying that “there needs to be an understanding that despite our profession we are still human beings and need just as much, if not more, support, as we take on so much – we hold everyone but ourselves”.

“We need to highlight the humanity of the person in the lab coat or nursing uniform.

We are humans first, with emotions and challenges as much as everyone else. Our qualifications and skills do not shield us from psychiatric illness, hence we are not immune and should not be viewed as ‘less than’ when we have challenges,” said another.

Dr Miric said the survey had highlighted the need to improve workplace support for mental health in the healthcare sector, with respondents calling for more education, awareness and open communication that acknowledged the challenges to mental health of working in healthcare.

“Healthcare professionals need to be reminded that they cannot pour from an empty cup, and that taking care of themselves enables them to serve others,” commented one respondent.

There is also a need to make support more easily accessible, greater awareness of

the resources and services that are available, and to ensure confidence in the privacy and confidentiality of support services.

“The respondents were clear that mental health and seeking help in the healthcare professions needs to be normalised and made a part of everyday language and interactions in healthcare workplaces, through actions such as regular workplace wellness check-ins and mental health care a standard part of the ‘package of care’ for those in the caring professions.

“Mental illness needs to be treated the same as physical illness in terms of medical aid, disability and income protection insurance, and workplace policies such as sick leave benefits,” she said.

Operations director of the South African Depression and Anxiety Group, Cassey Chambers said, “We know already that amongst healthcare workers, poor helpseeking behaviour exists where they are less likely to reach out for help or support due to stigma and fear. Through the HWCN, we are aiming to not only reduce the stigma associated with mental health but also to change the narrative and speak openly on accessing support when needed and being more aware of the warning signs.” * The HWCN network is a joint initiative of the South African Medical Association, the SA Depression and Anxiety Group, the SA Society of Psychiatrists, and the SA Society of Anaesthetists, supported by the Psychological Society of SA. Visit www. healthcareworkerscarenetwork.org.za for more information.

WHERE EXPERTISE AND COMMUNITY MEET VARIOUS PRACTICE OPPORTUNITIES AVAILABLE. Email practice@mediclinic.co.za

SOUTH AFRICA • SWITZERLAND • UAE • NAMIBIA www.mediclinic.co.za

MEDICAL CHRONICLE | May 2022 7

NEWS

Flu vaccine vital ahead of 5th wave With a significant rise in coronavirus infections across SA, all signs point to the country entering a fifth wave. Epidemiologists predicted the fifth wave would hit around winter, which is also associated with flu season. This raises the urgency for everyone to get their annual flu shot asap.

By Nicky Belseck, medical journalist

"O

NE OF THE BIG misnomers around influenza is often that it’s a nonserious illness,” said Dr Thinus Marais (Medical head: Africa Zone, Sanofi Pasteur). “But it’s important to note that it may result in hospitalisation and death.

You can see from the numbers worldwide, 3-5 million cases of severe illness, and 290 000-650 000 deaths per year because of influenza, so it's certainly not a non-severe illness by any stretch of the imagination,” he said at a recent media

briefing. “The influenza burden is often underestimated. When we talk about infectious diseases or vaccine-preventable diseases and we try to quantify the burden of disease, we often look at the number of deaths, hospitalisations and cases that

STAY A STEP AHEAD OF THE 2022 INFLUENZA SEASON Protect the vulnerable The NICD reported an atypical increase in Influenza cases in the summer months at the end of 20211

Influenza vaccination remains a primary means of preventing seasonal influenza infection1

Factors with the potential to impact Influenza season 2022 60%

Influenza infections dropped by 60 % during COVID-19 lockdown2 Reduced exposure to Influenza may mean reduced population immunity2 The easing of COVID-19 controls could result in an Influenza outbreak2

Drift in Influenza strain epidemiology (Southern hemisphere)3,4 2021 Season3

Groups at increased risk of severe complications include:1

Pregnant women1

HIV-infected individuals1 People with chronic illnesses (e.g. diabetes/cardiac patients)1 Obese individuals1

2022 Season4 People aged < 2 years and ≥ 65 years1

A/Victoria/2570/2019/ (H1N1)pdm09-like virus3

A/Victoria/2570/2019 (H1N1)pdm09-like virus4

A/Hong Kong/2671/2019 (H3N2)-like virus3

A/Darwin/9/2021 (H3N2)-like virus4

B/Washington/02/2019like (B/Victoria lineage) virus3

B/Austria/1359417/2021 (B/Victoria lineage)-like virus4

B/Phuket/3073/2013 (B/Yamagata lineage)-like virus3

B/Phuket/3073/2013 (B/Yamagata lineage)-like virus4

Be an ambassador for Influenza vaccination Healthcare provider recommendation is one of the most critical factors influencing vaccination5

The influenza vaccine may be co-administered with the COVID-19 vaccine, regardless of the timing6

GET A GRIP ON FLU

References: 1. NICD. ALERT: Increase in influenza cases in South Africa. Available from: https://www.nicd.ac.za/alert-increase-in-influenza-cases-in-south-africa/. Accessed date: 31 January 2022. 2. Lang K. Medical News Today. Lifting COVID-19 restrictions could lead to a large flu outbreak. Available from: https://www.medicalnewstoday.com/articles/take-the-flu-shot-experts-urge-as-lifting-covid-19-restrictions-could-trigger-flu-outbreak. Accessed date: 31 January 2022. 3. Blumberg L, Cohen C, Dawood H, et al.

NICD. Influenza NICD recommendations for the diagnosis, management, prevention and public health response. Available from: https://www.nicd.ac.za/wp-content/uploads/2021/07/Influenza-guidelines_-April-2021-final.pdf. Accessed date: 30 September 2021. 4. WHO. Recommended composition of influenza virus vaccines for use in the 2022 southern hemisphere influenza season. Available from: https://www.who.int/publications/m/item/recommended-composition-of-influenza-virus-vaccines-for-usein-the-2022-southern-hemisphere-influenza-season. Accessed date: 31 January 2022. 5. Henninger ML, Irving SA, Thompson M, et al. Factors Associated with Seasonal Influenza Vaccination in Pregnant Women. J Woman Health 2015;24(5):394-402.

6. National Department of Health. NATIONAL COVID-19 VACCINATION PROGRAMME CIRCULAR 3 OF 2022. Available at: https://sacoronavirus.co.za/2022/02/21/national-covid-19-vaccination-programmecircular-3-of-2022-co-administration-of-covid-19and-othervaccines/. Accessed date: February 2022.

17754

VAXIGRIP TETRA® Suspension for injection. 2022 strains. Each 0,5 ml suspension contains: A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/2570/2019, IVR-215) 15,0 μg; A/Darwin/9/2021 (H3N2) - like strain (A/Darwin/9/2021, IVR-228) 15,0 μg; B/Austria/1359417/2021 - like strain (B/Michigan/01/2021, wild type) 15,0 μg; B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, wild type) 15,0 μg. Reg. No.: 51/30.1/0838. VAXIGRIP TETRA® SIDE EFFECTS: The most frequently reported adverse reactions following VAXIGRIP TETRA® administration in adults and elderly were injection site pain; headache; myalgia and malaise. The most frequently reported adverse reactions following VAXIGRIP TETRA® administration in children and adolescents (3 to 17 years of age) were injection site pain; myalgia; headache; malaise and injection site swelling. For full prescribing information please refer to the Professional Information approved by SAHPRA (South African Health Products Regulatory Authority). Date of revision: November 2021. sanofi-aventis south africa (pty) ltd, reg. no.: 1996/010381/07. Floor 5, Building I, Hertford Office Park, 90 Bekker Road, Midrand, 2196. Tel: (011) 256 3700. Fax: (011) 256 3707. www.sanofipasteur.com For Medical Information Enquiries kindly contact ZAvaccine.queries@sanofi.com MAT-ZA-2101382-1.0 - 04/2022.

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8 May 2022 | MEDICAL CHRONICLE

2022/04/25 13:41

are reported within a season. In SA there are over 11 000 deaths, close to 23 000 hospitalisations, and more than 10 million cases per season. From a classical burden of disease perspective this is already a heavy burden on our healthcare system, but what’s often neglected is what influenza does beyond flu, beyond the disease that it causes,” Dr Marais said.

“Influenza influences heart attack, stroke and deconditioning. It can also worsen some underlying chronic conditions in individuals who contract the disease – diabetics, asthmatics, people with COPD, and anyone with renal complications,” explained Dr Marais.

“If we look at heart attack as an example, someone who contracts influenza, in the first week of contracting the disease has a tenfold increased risk of potential heart attack. Inversely, if individuals are vaccinated against influenza, the vaccine can have a preventative effect of up to 15%45%. That’s equivalent to someone who stops smoking or takes high blood pressure medication as an intervention.”

INFLUENZA AND COVID-19 It's important for patients to understand that they can in fact get influenza and Covid-19 at the same time and to caution them that co-infection can result in severe disease. Dr Marais explained that studies have shown that there’s a two times higher intensive care unit admission for patients that are co-infected with both influenza and Covid-19 compared with patients with just one of the infections alone. And there’s a two times higher risk of death in patients with a co-infection compared with those suffering from just one infection.

This is significant because both diseases are vaccine preventable,” said Dr Marais.

“Trying to prevent one or both of these diseases is certainly helpful in determining your outcome should you contract one or both of the diseases.”

FLU VACCINE “Fortunately, there are modalities available to us to prevent influenza. Effective vaccines have existed for more than 80 years,” said Dr Marais.

“Seasonal influenza vaccines have saved countless lives and limited pandemic spread. Quadrivalent (QIV) vaccines, which were made available in SA in 2020 protect against four influenza viruses – two sub-types of type A and two lineages of type B strains.”

While the earlier you vaccinate before the season the better your odds are of being protected as the season starts.

Dr Marais stressed that it’s important for patients to know that it’s never too late to vaccinate.

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References: 1. DISCOVERY HEALTH MEDICAL SCHEME. CHRONIC ILLNESS BENEFIT MEDICINE LIST (FORMULARY) 2021, [Online] Available at URL: https://www.discovery.co.za/wcm/discoverycoza/assets/medical-aid/benefit-information/2021/chronic-illness-benefitmedicine-list-formulary-2021.pdf. Accessed 11 January 2021. 2. Data on File. CDL Formulary Negotiations 2020 and 2021.

S3 NovoRapid® (100 units Insulin Aspart). Registration number: 34/21.1/0160. For full prescribing information, please refer to the Professional Information approved by the Medicines Regulatory Authority.

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Novo Nordisk (Pty) Ltd. Reg. No.: 1959/000833/07. 150 Rivonia Road, 10 Marion Street Office Park, Building C1, Sandton, Johannesburg, 2196. Tel: (011) 202 0500 Fax: (011) 807 7989. www.novonordisk.za.com. Fax: (011) 807 7989. www.novonordisk.com.

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COMPANY PROFILE

Acino

committed to expansion and localisation A global vision-local focus approach is showing the industry what international power with home-grown, on the ground experience and leadership can achieve in bringing healthy development to a nation.

A

CINO’S RECENT ACQUISITION of six prescription medicines from Aspen, for over R1.8bn, is just one of the most recent steps in the multinational pharmaceutical company’s history, which dates all the way back to 1836 when the company – then named 'Schweizerhall' – was founded near Basel, Switzerland.

A LONG-ESTABLISHED AND PROVEN TRACK RECORD “From 1836 to 2008 the company was largely focused on manufacturing and business to business (B2B),” John Norman (Acino regional director English speaking Africa) said in an interview with Medical Chronicle’s Nicky Belseck. “It was only after the Acino acquisition, the delisting of the company from the Swiss Exchange (SIX) that the company transitioned to a business to customer, B2C model. As it stands today, it’s almost two different business structures. One that focuses on B2B, and another that focuses on B2C. Obviously the manufacturing of products is both to other countries and to the countries where Acino’s based.”

The name ‘Acino’ came about in 2008. “It was the merging of the names of Cimex Pharma (acquired in 2004) and Novosis from Germany (acquired in 2006),” explained Norman. “They combined the first two letters from each name and put an ‘A’ in front – ‘Acino’.

“In 2011 Acino made a rather big acquisition of a business called Mepha. Two years later, in 2013, that deal translated into the two private equity companies, Nordic Capital and Avista Capital, merging and acquiring Acino, which they then delisted from the Six Swiss Exchange in 2014. The B2C part of our business then started to escalate. There were several acquisitions across the world – in Russia and Ukraine, Acino also acquired Pharma Start in 2015,

10 May 2022 | MEDICAL CHRONICLE

the Ukraine manufacturing plant and the Takeda plant in Estonia, which is quite an important facility for us today,” said Norman.

“Then in 2017 there was the SA acquisition of Litha Healthcare and they signed quite a big distribution in the Commonwealth of Independent States (CIS). In 2020 Acino completed the acquisition of Takeda assets for primary care portfolio in selected emerging markets, including Middle East Africa and Ukraine.

This enabled us to set up operations in Turkey and Egypt. “In 2021 we made another acquisition in Russia, and most recently, we made the acquisition of assets from Aspen which cost us R1.8bn,” Norman said. This acquisition further strengthens Acino’s South African portfolio of gastroenterology, erectile dysfunction and cardiovascular disease therapies.

LEVEL 1 BBBEE CERTIFICATE Not only is Acino the only multinational pharmaceutical company with Level 1 B-BBEE certification, but the company has just attained Level 1 B-BBEE status for the third year in a row. “A Level 1 B-BBEE certificate is not only a certificate of achievement, but also testimony to our committed investment into SA,” said Norman. “It is a certificate of potential, the potential of the healthcare industry to bring meaningful change to people’s lives.

“At the end of the day, while we’re a big company and we deal with other big organisations, there was always room within our business, particularly from a procurement point of view to support smaller businesses, to support empowerment businesses etc,” Norman added. “When President Cyril Ramaphosa launched the YES (Youth Employment Services) initiative it was also something that we embraced. I think at the end of the day you have a corporate social responsibility

programme and it’s not something you want to go out and advertise, we do it because we feel it is important to put something back into the community, and the YES initiative fitted our strategy, it just so happens to also support your scorecard.”

INTERNAL LEARNERSHIP PROGRAMME “When we took a decision that we would develop our own resources internally,” said Norman. This resulted in Acino’s internal learnership programmes, which has a thirdparty accredited service provider, where on average 10 students are developed over a 12-month period. “Apart from having the workplace experience and sitting in a classroom learning different aspects about the business, they also get to go out with a sales representative and get practical experience,” Norman explained. The programme has been so successful that over the last four years at least 75% of these learners have become full-time employees at Acino. “What we’ve learnt over the years is that with the high unemployment, university graduates require an opportunity to gain experience. Because in most instances that’s the first requirement when applying for a job. But how do you get experience if you’ve just left university? So, we’ve opened that door, and it’s become so successful that we’re starting to recruit those people ourselves,” said Norman. “We’re almost developing the next generation of employees for Acino.”

FUTURE PLANS Acino’s plans for the future are all about affordable healthcare solutions, expansion, and localisation. Norman gave the recent R1.8m Aspen acquisition as an example explaining that along with the acquired assets, Acino signed a seven-year manufacturing and supply agreement.

“So, what we’ve done is we’ve brought global investment into the SA market and we’re looking at continuing the relationship John Norman, Acino with Aspen regional director English in terms of speaking Africa manufacturing and supply for at least seven years.

“Also, from an Acino perspective, our senior management in Switzerland and our board have endorsed our transformation, our localisation, and are in full support of the broad based black economic empowerment certification, so I think it’s a really important factor that differentiates us from most other multinationals.

“I think what the future holds for us is that we’re looking to expand our business more, we’re looking at additional acquisitions, we’re not only looking at buying assets and companies, but we’re also looking at other aspects of the supply chain that are important. The more we can localise, the more jobs we can create in SA, I think the better it is for the economy, and we’ll continue to look at that through localisation,” said Norman. “One of the things Covid taught us is that it’s become very expensive to import products due to the increasing costs of airfreighting, sea freighting is becoming dominant but also that’s supply and demand. So, the more we do locally, the better it is in terms of sustainability. We might not be manufacturing all our products, but we certainly can be doing secondary packaging as an additional element.

“Acino is here to grow, and we’re here to make a difference in the SA healthcare sector,” Norman concluded.

An investment IN HEALTHCARE IS AN INVESTMENT IN OUR NATION HEALTH GOES BEYOND EACH INDIVIDUAL WHO USES OUR QUALITY, AFFORDABLE PRODUCTS. IT EXTENDS INTO A NATION. We are a healthcare company with a global vision and a very local focus – investing in the providers, patients, and people of South Africa. From our internal processes to our external products, Acino is dedicated to making a difference in peoples’ lives.

• Specialised disease areas, Over the Counter, Generics and devices for our nation’s health • Level 1 B-BBEE • Truly representational workforce of over 200 people reflecting all South Africans • Learnership programmes and CSIs to grow our people nationwide • Skills development • Quality, affordable healthcare for all South Africans

WE ARE COMMITTED TO IMPROVING PATIENTS’ LIVES

BY DELIVERING HIGH QUALITY PRODUCTS TO LEARN MORE VISIT WWW.ACINO.CO.ZA Litha Pharma (Pty) Ltd. Reg. no.: 1994/008717/07. No 106, 16th Road, Midrand, 1686, Gauteng, South Africa. (011) 516-1700. www.acino. co.za. LP4120 05/2022. Exp. 05/2024

PRACTICE MANAGEMENT

Limiting fraud in the healthcare practice

One of the most significant concerns any healthcare practice faces is the possibility of fraud. Practitioners can become so focused on patient care that it is easy to neglect the proper management of financial and other risks.

F

URTHERMORE, SINCE PRACTITIONERS and personnel work so closely together and function within a high trust environment, no practitioner wants to even think about their personnel not honouring the trust relationship expected of any employee.

Unfortunately, an employee under financial pressure and the opportunity created by a healthcare practice with poor controls can lead to fraud and rationalising why the fraudulent acts are justified.

Rather than suffering the consequences, the practice should eliminate those opportunities as far as possible and help keep personnel honest.

So, what are the measures that owners can take to limit the possibility of fraud?

1. User access pertinent to roles in the practice A careful role division in the practice enables it to divide work optimally between personnel and implement a separation of duties and corresponding user access.

Typical roles in the practice would be the practitioner, practice manager, receptionist, billing expert, cashier, stock controller and bookkeeper.

Users can fulfil the responsibilities of one or more roles, depending on the size of the practice, and they should have limited access to functions and information in the software system.

The practice can predefine these roles in the software, and new users can receive access pertinent to their roles. Typically, the owner will have full access, but other users will have limited access to functions like journals that are open to abuse.

12 May 2022 | MEDICAL CHRONICLE

Kobus Wolvaardt, CEO and development strategist of GoodX Sagteware

to mobile devices, computer systems, network services and data. The WebAuthn standard has fobs that act like keys (simply having it unlocks the website) and others that even support fingerprint unlock, with pricing to match your taste. As a bonus, these keys can be used for Google, Facebook and many other websites.

3. Financial controls There are numerous ways of dealing with cash and other payments in the practice to mitigate the risk of fraud. The first important aspect to consider is using practice management software which is fully integrated with an auditable doubleentry financial accounting system. A double-entry system eliminates the risks of managing multiple systems and provides sufficient audit trails and reporting.

2. Access control to software Once users have access to software, it is necessary to safeguard that access.

Access control is established when only a particular user can utilise their username and password. Users should never reveal their passwords to anybody, nor should more than one person share a workstation and use the same username and password.

In addition, most software keeps an audit trail of all changes made in the software, so if a user account is used for unauthorised

changes, the user will be held liable for those changes.

Passwords should be changed regularly to mitigate them from becoming compromised. A Web Authentication (WebAuthn) key fob (Two Factor Authentication) is a great solution to remove the risk of forgotten passwords or written down passwords becoming available to unauthorised users. A key fob is a small security hardware device with built-in authentication to control and secure access

The following processes can be implemented to reduce financial loss: 1. A cash register system that is reconciled at the end of every workday 2. Payment links sent to patients reduce the risk associated with cash 3. Regular stock takes 4. Regular reporting and the performance of other internal controls 5. Limiting and checking all journal entries and reasons provided for them.

From the above discussion, which is not comprehensive, there are numerous steps the practice can take to mitigate the risk of fraud. Prevention is better than cure and limiting opportunity goes a long way in creating a safe environment for both owners and employees to work together for the benefit of all.

CLINICAL | OPHTHALMOLOGY

Dry eyes cause tears Tears provide lubrication to help vision and keep the eyes comfortable.

T

HE PREVALENCE OF dry eye disease in South Africa is reported to be as high as almost 55% (Akowuah et al, 2020). This is likely to be higher because of the increased screentime due to people working remotely. Staring at computer screens for many hours at a time suppresses our blink reflex, which leads to more dry eyes.

Sometimes, dry eyes create too many tears. This confusing condition is called reflex tearing. It happens because the lack of moisture irritates the eye. It sends a distress signal through the nervous system for more lubrication. The body sends a flood of tears to try to make up for the dryness. But these tears are mostly water, so they don’t act like normal tears. They can wash debris away,

but they can’t coat the eye’s surface. Eyes may also be prone to bacterial infections, or the surface of the eyes may become inflamed, causing scarring on the cornea.

SYMPTOMS It is a symptomatic disease, characterised by a vicious cycle of tear film instability and hyperosmolarity, which leads to increased

Feel Unstoppable with Fast-Acting Dry Eye Relief

RISK FACTORS DED is common, it can be situational – caused by environmental factors or it could be chronic – caused by age, gender, hormones (pregnancy, those on hormone replacement therapy, or menopause) medications or surgery.

2 DROPS, 1 UNSTOPPABLE YOU

FAST-ACTING RELIEF 1,2

The most common symptoms of dry eye disease (DED) are: • Burning • Pain • Redness • Watery tearing • Stringy mucus • Eyes get tired faster than they used to • Difficulty reading or sitting at the computer for long periods • Blurry vision • Feeling of having sandy/ gritty eyes.

Many people with dry eyes notice that their eyes feel heavy.

1,2

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ocular surface inflammation, damage and neurosensory abnormalities.

2X MORE LUBRICITY 3*

* Compared to Hyaluronic acid (HA) alone.

1. Davitt, WF, Bloomenstein M, Christensen M, Martin AE. Efficacy in patients with dry eye after treatment with a new lubricant eye drop formulation. J Ocul Pharmacol Ther. 2010;26(4):347-353. 2. Christensen MT, Martin AE, Bloomenstein M. A comparison of efficacy between Systane Ultra and Optive lubricant eye drops when tested with dry eye patients. Optometry. 2009;80(6):315. 3. Rangarajan R, Kraybill B, Ogundele A, Ketelson H. Effects of a Hyaluronic Acid/Hydroxypropyl Guar Ar tificial Tear Solution on Protection, Recovery, and Lubricity in Models of Corneal Epithelium. J. Ocul. Pharmacol. Ther. 2015;31(8):491-497. ©2020 Alcon Inc. 09/2020 ZA-SYZ-2000003 Alcon Laboratories (South Africa) Pty (Ltd) P.O Box 12257, Vorna Valley, 1686 Office: Magwa Crescent West, Waterfall City, Jukskei View, 2090 Tel: 011 347 6600. Co Reg No. 1977/000460/07.

MANAGEMENT The management of DED is complicated, due to its multifactorial aetiology. Clinicians must make their best efforts to identify the degree to which evaporative dry eye, aqueous deficient dry eye and/or other ocular surface conditions are contributing to the patient's presentation.

The ultimate aim of DED management is to restore the homeostasis of the ocular surface and tear film, through breaking the vicious cycle of the disease.

While certain treatments may be specifically indicated for one particular aspect of an individual patient's condition, a number of therapies might be appropriately recommended in order to treat the multiple aspects of a patient's presentation with DED. While aiming to identify and treat the primary source of the disease, the management of DED typically involves ongoing management to address chronic sequelae, rather than short-term treatment.

In general, management begins with conventional, low-risk and easily accessible patient-applied therapies such as over-thecounter lubricants for early stage disease, and progresses to more advanced therapies for more severe forms of DED. Use nonpreserved ocular lubricants to minimise preservative-induced toxicity.

All eye care providers who treat patients with DED must exercise their clinical skills to judge the significance of each of the varied pathogenic processes that may manifest similar subjective complaints and similar signs of ocular surface dysfunction.

References available on request.

9192 Alcon A4 MDPF .indd 1

14 May 2022 | MEDICAL CHRONICLE

2021/11/03 15:10

Quality of life in COPD

CLINICAL | RESPIRATORY

Over the last few years, there has been a continued global interest in pharmacological interventions, non-pharmacological measures and mental health programmes that may improve the quality of life (QoL) in patients with COPD.1

HARMACOLOGICAL THERAPY IN COPD patients is used to reduce symptoms, reduce the frequency and severity of exacerbations, and improve exercise tolerance and health status.2 Long-acting muscarinic antagonists (LAMAs) like tiotropium bromide may be used as a first-line treatment in patients with moderate to severe disease.3 Tiotropium bromide may be used as monotherapy and in combination with long-acting beta2 agonists (LABAs).3 In most comparative studies of tiotropium and placebo, ipratropium or salmeterol, tiotropium provided significant beneficial effects on lung function, including improvements in FEV1 (forced expiratory volume in one second) and FVC (forced vital capacity).3 In SA, tiotropium bromide is indicated for the long-term maintenance treatment of COPD, including chronic bronchitis and chronic bronchitis associated with emphysema.4 It has a slow onset of peak bronchodilation, but a 24-hour duration of action facilitating once-daily administration.4,5 With over 10 years' prescribing history and 50 million patientyears of use, tiotropium has the benefit of a more extensive clinical evidence base relative to other long-acting bronchodilators, with demonstrated efficacy and safety in COPD.6 BRONCHODILATORS The 2022 update of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy document highlights the following strong evidence regarding the use of bronchodilators in patients with stable COPD:2 • Both LABAs and LAMAs significantly improve lung function, dyspnoea, health status and reduced exacerbation rates • LAMAs have a greater effect on exacerbation reduction compared with LABAs and has decreased hospitalisations • Combination treatment with LABA and LAMAs increases the FEV1 and reduces symptoms compared to monotherapy • Tiotropium bromide improves the effectiveness of pulmonary rehabilitation in increasing exercise performance.

PULMONARY REHABILITATION Pulmonary rehabilitation is a core component in the management of patients with moderate to severe COPD, and includes patient tailored therapies (exercise training, education and behaviour change), which are designed to improve the physical and psychological condition of patients.7 Pulmonary rehabilitation has been shown to reduce the symptoms of anxiety and depression, reduce hospitalisation in patients with recent exacerbations, and improve health status and exercise tolerance in stable patients.2

THE LOCAL SITUATION Cape Town had the highest prevalence of stage 2 COPD (19% overall, 22% male and 17% female).5 Smoking is a major cause of COPD and additional factors such as HIV infection, exposure to biomass fuels and tuberculosis (TB) points to a high prevalence of COPD in SA, which is expected to rise

over the next few years.5 The prospect of an affordable tiotropium generic may be of value to COPD patients in lower to middle income countries (LMICs) like SA. LMICs face many research challenges such as lack of human resources, planning and finance and technology limitations.1 Therefore, the support of

higher income countries (HICs) and active participation in ongoing research with HICs, is critical to improve the understanding and management of COPD in LMICs.1

References available on request.

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References: 1. Tiores Professional Information November 2020. 2. Database of Medicine Prices July 2021. 3. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (2020 Report) [Internet]. 2020 p. 45. Available from: https://goldcopd.org/wp-content/uploads/2019/12/GOLD-2020-FINAL-ver1.203Dec19_WMV.pdf S3 TIORES. Reg. no.: 50/10.2.1/0671. Each capsule for inhalation contains 15,6 μg tiotropium bromide equivalent to 13 μg tiotropium with a delivered dose of 10 μg tiotropium. For full prescribing information refer to the professional information approved by the South African Health Products Regulatory Authority. Date of publication: November 2020. Applicant: Forrester Pharma (Pty) Ltd, Tel: (021) 943 0600. Marketed by: Glenmark Pharmaceuticals South Africa (Pty) Ltd, 2nd Floor, Building D, Stoneridge R E S P I R A T O R Y Office Park, 8 Greenstone Place, Greenstone, Edenvale, Gauteng, 1609. Tel: (011) 564 3900. www.

Glenmark, touching the lives of glenmarkpharma.co.za. TIORAD/10/21.

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MEDICAL CHRONICLE | May 2022 15

CLINICAL | DIABETES

Type 1 diabetes

The burden of mealtime insulin dosing Timely and accurate mealtime insulin dosing can be an ongoing challenge for people with type 1 diabetes.

I

NCORRECT ADMINISTRATION OF insulin (eg, too little, too much, or at wrong times) can result in transient and serious hypo- and hyperglycemia, wide glycemic excursions, and diabetic ketoacidosis.

A multinational, online study (Lane et al 2021) aimed to explore attitudes and behaviors around mealtime insulin dosing and the impact of mealtime dose timing, particularly with regard to premeal dosing (15-20 minutes before a meal).

• Although the majority of surveyed participants (96%) recognised the importance of accurate mealtime bolus insulin dosing, only a small proportion (35%) reported being 'very confident' in accurate bolus insulin estimation.

• Most responding adults with type 1 diabetes (91%) and parents of children with type 1 diabetes (97%) experienced challenge(s) related to premeal insulin dosing.

• Most responding adults with type 1 diabetes (91%) and parents of children with type 1 diabetes (92%) reported worrying about postmeal glucose levels at least occasionally.

• A high proportion of responding adults with type 1 diabetes (67%) and parents of children with type 1 diabetes (72%) said that having the freedom to administer mealtime insulin immediately before or after the start of a meal rather than 15-20 minutes before the meal would have a positive impact on their lives.

time to administer a rapid-acting insulin analogue is 15-20 minutes before the start of a meal. This recommendation follows observations in general practice and studies evaluating the effect on PPG excursions of dose timing of rapid-acting insulin relative to meals in people with type 1 diabetes.

Premeal bolusing of rapid-acting insulin analogues 15 minutes before mealtime resulted in lower PPG excursions and more time spent in the euglycemic range (3.5–10mmol/L) without increased risk of hypoglycaemia.

Despite these results and clinical recommendations, real-world studies have demonstrated poor adherence to the recommended injection-to-meal interval, and postmeal bolus dosing is commonly observed. Synchronising the administration of insulin with its anticipated effect on glucose absorption poses a significant challenge for many people with diabetes, especially children or anyone who struggles to adhere to lifestyle routines. Some of the challenges associated with mealtime insulin dosing include injection pain, embarrassment, and interference with daily activities.

A large proportion of people with type 1 diabetes, both adults and children, do not achieve guideline-recommended A1C targets. Contributing to overall glycaemic burden is postprandial glucose (PPG), which, together with fasting plasma glucose, is a target measure that is incorporated into guideline recommendations. Elevated PPG levels have been shown to be associated with a significant increase in health care resource utilisation, including clinic visits, calls, emails to health care providers, and hospitalisations among adults with diabetes who use a multiple daily injection insulin (MDI) regimen. However, managing PPG remains one of the most challenging aspects of diabetes care.

Optimal timing of mealtime insulin dosing is a key factor in controlling PPG levels.

Multiple studies and clinical practice guidelines have suggested that the optimal

DISCUSSION The study authors conducted a multinational survey with >1 700 people with type 1 diabetes and >900 physicians with experience treating people with type 1 diabetes to assess perceptions, challenges, and impact of and behaviours associated with mealtime insulin dosing.

Not surprisingly, adjusting insulin dose to meals, or vice versa, was a key challenge reported by people with type 1 diabetes and their treating physicians. Accordingly, the need for additional food intake or additional insulin was reported frequently as necessary corrective actions occurring on at least a weekly basis. Parents of children with type 1 diabetes were more likely than adults with diabetes to report these challenges, as it is more difficult to predict the amount of food a child will eat. Consequently, at least half of surveyed participants resorted to postmeal insulin administration at least once a week.

It follows that the majority of surveyed

KEY POINTS

16 May 2022 | MEDICAL CHRONICLE

people with type 1 diabetes and physicians felt that the need for premeal insulin administration has a negative impact on lifestyle and that an option to administer mealtime insulin immediately before or immediately after a meal would improve quality of life. This finding highlights the need for better education of people with type 1 diabetes around the correct adjustment of bolus insulin doses before meals. Additional food intake or insulin dosing should not be required as a postmeal corrective action.

Rapid-acting insulin analogues (ie, insulin lispro, insulin glulisine, and insulin aspart) are generally recommended for use before a meal, and clinical guidelines recommend premeal insulin administration.

When initially introduced, however, this first generation of mealtime insulin was also approved for postmeal administration, but this practice is now generally recognised as suboptimal, as it can result in higher A1C levels (compared with premeal administration of bolus insulin), postprandial hyper- and hypoglycaemia, and ensuing complications. The importance of PPG is now widely accepted and is reflected in new guidelines. Fast-acting insulin aspart, one of the first ultra-fast-acting insulin analogues, approved in 2017, has a quicker onset and offset of action and a greater early glucoselowering effect than insulin aspart. Mealtime administration (specifically defined here as 0-2 minutes before a meal) of fast-acting insulin aspart showed noninferiority in A1C reduction and improved PPG control compared with insulin aspart in both adults with type 1 or type 2 diabetes (with or without an insulin pump) and children with type 1 diabetes. In a phase 3 treat-to-target trial in adults with type 1 diabetes, subjects randomised to postmeal faster aspart (20 minutes after the start of a meal) for all meals maintained A1C noninferior to that obtained with mealtime insulin aspart.

Improvements in PPG control have also been shown with the mealtime administration of ultra-rapid lispro (URLi), indicated for the treatment of type 1 or type 2 diabetes and inhaled Technosphere insulin in adults with type 1 diabetes. In a phase

3 treat-to-target trial in adults with type 1 diabetes, both mealtime and postmeal URLi demonstrated noninferiority to insulin lispro for change in A1C, and mealtime URLi was superior to insulin lispro in reducing PPG excursions.

The improved time-action profile, more rapid onset of action, and demonstrated efficacy of ultra-fast-acting compared with rapid-acting insulin analogues might indeed help to alleviate the need for corrective actions after meals and facilitate more flexible insulin dosing around meals while mitigating concerns about PPG excursions.

CONCLUSION In summary, this study provides real-world insight into the challenges and behaviours associated with premeal insulin dosing in people with type 1 diabetes. The importance of injection timing is not always discussed by physicians, even though it is critical to achieving PPG control. Although the importance of accurate and timely dosing was recognised, premeal insulin administration poses a clear challenge to people with type 1 diabetes. Given the choice, participants said they would prefer mealtime or even postmeal administration as being clearly advantageous and beneficial to quality of life. Given the high proportion of people with type 1 diabetes with missed insulin boluses, more convenient timing may also aid therapeutic adherence.

The advent of ultra-rapid insulin analogues now presents a possible solution to some of these issues. Physicians should aim to explore the issues around administration of insulin with meals and address their patients’ needs through support, education, and, where clinically appropriate, consideration of ultra-rapid insulin therapy.

REFERENCES Lane W, Lambert E, George J, et al. Exploring the Burden of Mealtime Insulin Dosing in Adults and Children With Type 1 Diabetes. Clin Diabetes.

2021;39(4):347-357. doi:10.2337/cd20-0117.

Trief PM, Cibula D, Rodriguez E, et al. Incorrect Insulin Administration: A Problem That Warrants Attention.

Clin Diabetes. 2016;34(1):25-33. doi:10.2337/ diaclin.34.1.25

Do your patients often dose postmeal because they’re unsure of what they’ll eat? Maria* does Fiasp® can be administered at the start of a meal, with the option to administer even 20 minutes after starting a meal1

…and demonstrates proven reductions in PPG1,2

With the option to inject closer† to her meal1‡, Maria can enjoy lunch with her colleagues without worrying about her dose

*Model shown is not a real patient and results shown do not reflect model’s experiences.

COMING SOON Fiasp® offers a faster† response1,2^ to keep up with how quickly life moves PPG: Post prandial glucose. ^Both dosed at mealtime; data from onset 1 trial in adults with type 1 diabetes. PPG measured at 1 hour (P<0.0001) and 2 hours (P=0.0375). †vs NovoRapid®. ‡Fiasp® can be administered at the start of a meal, with the option to dose 20 minutes after starting the meal.

References: 1. Fiasp® Professional Information, December 2020. 2. Russell-Jones D et al. Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (Onset 1). Diabetes Care. 2017;40(7):943–950.

Abbreviated Professional Information Abbreviated Professional Information: Scheduling status: S3 Name of the medicine: Fiasp® Qualitative and quantitative composition: Contains insulin aspart 100 U/ml. Therapeutic indications: Maintenance treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above, used alone or in combination with other insulins or metformin. Posology and method of administration: Fiasp® is a mealtime insulin for subcutaneous administration at the start of a meal or post-meal (within 20 minutes after starting a meal). Dosing with Fiasp® is individual and determined in accordance with the needs of the patient. The individual total daily insulin requirement in adults, adolescents and children may vary and is usually between 0,5 and 1,0 unit/kg/day. Fiasp® should be used in combination with intermediate-acting or long-acting insulin given at least once a day. Blood glucose monitoring and insulin dose adjustment are recommended to achieve optimal glycaemic control. Converting from another mealtime insulin can be done on a unit-to-unit basis. Close glucose monitoring is recommended during the transfer from other mealtime insulins and in the initial weeks thereafter. Fiasp® can be used for continuous subcutaneous insulin infusion (CSII) in pumps. If necessary, Fiasp® can be administered intravenously by health care professionals. Contraindication: Hypersensitivity to the insulin aspart or any of the excipients and during episodes of hypoglycaemia. Special warnings and precautions for use: The safe use of Fiasp® in treatment of ketoacidosis has not been established. Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. Patients, whose blood glucose control is greatly improved, e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia, and should be advised accordingly. Usual warning symptoms may disappear in patients with longstanding diabetes. In Paediatric population close monitoring of blood glucose levels is recommended if administering Fiasp® after the start of the last meal of the day, in order to avoid nocturnal hypoglycaemia. The fast onset of action should be considered in patients with delayed gastric emptying. Cases of congestive heart failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of congestive heart failure. Patients should be observed for signs and symptoms of congestive heart failure, weight gain and oedema. The use of inadequate doses or discontinuation of treatment, especially in patients requiring insulin, may lead to hyperglycaemia and diabetic ketoacidosis. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs. Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between Fiasp® and other insulin medicines. Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland may require changes in the insulin dose. Insulin administration may cause insulin antibodies to form. The presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia. Pregnancy and lactation: Safety in pregnancy and lactation has not been established. There are no restrictions on treatment with Fiasp® during breastfeeding as insulin aspart does not cross into breast milk. Undesirable effects: Very common: Hypoglycaemia; Common: Allergic skin manifestations, injection/infusion site reactions; Uncommon: Hypersensitivity, lipodystrophy, eruptions, refraction, diabetic retinopathy, oedema; Rare: Peripheral neuropathy; Very rare: Anaphylactic reactions; Unknown: Cutaneous amyloidosis. Overdose: Hypoglycaemia may develop over sequential stages if a patient is dosed with more insulin than required: Reg. No.: 51/21.1/0733 For full prescribing information, refer to the Professional Information approved by the Regulatory Authority.

Novo Nordisk (Pty) Ltd. Reg. No.: 1959/000833/07. 150 Rivonia Road, 10 Marion Street Office Park, Building C1, Sandton, Johannesburg, 2196, South Africa.

Tel: (011) 202 0500. Fax: (011) 807 7989. www.novonordisk.com. 19450T. ZA22FSP00007 January 2022.

MEDICAL CHRONICLE | May 2022 17

ONLINE CPD

CPD: Getting rid of actinic keratosis

Actinic keratoses (AKs) are usually benign but can potentially transform into invasive squamous cell carcinoma (SCC).

To prevent this, a variety of treatment options are available, with various topical field therapies being most effective.

This is a summary of a CPD article on www.medicalacademic.co.za. Find the article and take the quiz for CPD points.

A

FTER PROLONGED SUN exposure, actinic keratosis (AK) develops on the face, lips, back of neck, hands, and exposed areas of scalp. On exposed skin, it appears as a rough, dry, scaly area or growth.

The blemishes are frequently raised, have a rough feel, and resemble warts. AK patients may have one or several blemishes. They are one of the most common skin conditions treated by dermatologists.

PREVALENCE AK is more common in people with Fitzpatrick skin types I and II, according to numerous studies. Additionally, when compared to individuals between the ages

The First Generic Imiquimod cream in SA!

ACTINIC KERATOSIS

ACTINIC KERATOSIS (AK)

Reflectance confocal microscopy (RCM) studies have shown that field therapies, such as imiquimod, can clear subclinical lesions1 Guidelines for the Treatment of Actinic Keratosis2 In patients who have single AK lesions In patients who have multiple AK lesions For immunocompromised patients with AK Cosmetically superior to cryotherapy2 Excellent cosmetic outcome reported Better skin appearance reported

References: 1. Stockfleth E. The importance of treating the field in actinic keratosis. JEADV,2017;31(2):8-11. 2. Werner RN, Jacobs A, Rosumeck S et al.

Methods and Results Report – Evidence and consensus based (S3) Guidelines for the Treatment of Actinic Keratosis – International League of Dermatological Societies in cooperation with the European Dermatology Forum. J Eur Acad Dermatol Venereol 2015; 29, e1–e66.

S4 GLENTRIZ™ CREAM 5 % w/w (Cream). Reg. No.: 49/34/0556. Each 250 mg sachet contains 12,5 mg of imiquimod. For full prescribing information refer to the professional information approved by the South African Health Products Regulatory Authority. HCR: Glenmark Pharmaceuticals South Africa (Pty) Ltd, 2nd Floor, Building D, Stoneridge Office Park, 8 Greenstone Place, Greenstone, Edenvale, Gauteng, 1609, Tel: +27 (0)11 564 3900. www.glenmarkpharma.co.za.

of 50 and 59, those over the age of 80 are six times more likely to develop AKs. Studies have found that men have a higher prevalence of AK than women, which may be due to higher rates of sun exposure.

According to a study conducted in England, 15.4% of men and 5.9% of women in their 40s develop AK. Over the age of 70, those percentages rise to 34.1% in men and 18.2% in women, respectively.

TREATMENT OPTIONS AK treatment modalities are based on destroying the affected parts of the skin.

Curettage, liquid nitrogen cryotherapy, topical chemotherapeutics, and chemical peels are among them. Immunomodulators have also been employed successfully in the past. Treatment options are determined by a clinical review that considers the severity of the ailment, the benefits and drawbacks of each therapy, and the cost.

A growing body of medical opinion believes that AKs are part of a continuum that includes SCC in situ, and that treatment is thus necessary to avoid SCC. An exhaustive recent Cochrane evaluation of AK therapy, on the other hand, found no indication that AK treatment reduced the development of invasive SCC. There is insufficient evidence to support treating all AKs in the hopes of preventing malignancy. Once it has been determined that pharmacological therapy is needed, it is vitally important to understand that, since AKs can progress to SCC, any therapies chosen must be able to clear both clinical and subclinical lesions across the entire affected field to reduce the likelihood of disease recurrence and minimise progression to invasive SCC. 5-fluorouracil (5-FU), topical nonsteroidal anti-inflammatory medications (diclofenac, piroxicam), immunomodulators (imiquimod and ingenol mebutate), and photodynamic therapy are all examples of field therapy for AKs. CONCLUSION The treatment of AKs, often necessitated by the possibility of its progression into invasive SCC, should take the potential presence of subclinical lesions into account.

Patients should be available for regular follow-up appointments and must be educated on the need to adhere to their treatment. Of the available AK treatments, imiquimod demonstrates clear effectiveness in terms of long-term clearance and the prevention of recurrence. In most cases, the 3.75% formulation is preferred over the 5% one.

References available on request.

18 May 2022 | MEDICAL CHRONICLE

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Date: 28th June 2022 Time: 19h00 Presenter: Dr Leon Levin Topic: An Approach to HIV Treatment Failure Dr Leon Levin

MBBCh(Wits), FCPaed(SA), DTM&H

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Dr Leon Levin MBBCh(Wits), FCPaed(SA), DTM&H is a paediatrician who has been treating HIV infected infants, children and adolescents for the past 26 years. From 2013-2018 he was Head of Paediatric HIV Programmes and is currently Senior Technical Advisor in Paediatrics at Right to Care NGO. He was the Chairman of the Paediatric Subcommittee of the SA HIV Clinicians Society from 1999-2011 and was the convenor of the Southern African HIV Clinicians Society Paediatric Antiretroviral Guidelines 2000, 2002 and 2005 and Co-

convenor for the 2009 guidelines. He has been on the SA DOH Paediatric and Adolescent ART Guidelines Committees and is on the Paediatric 3rd line ART Committee for the SA DOH. He is Paediatric HIV Medical advisor to one of the larger Medical AIDs He has given numerous lectures and HIV viral resistance workshops throughout Africa. His Current areas of interest include infants, children and adolescents with HIV infection, new paediatric ART formulations, treatment failure and drug resistance and HIV disclosure to adolescents.

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MEDICAL CHRONICLE | May 2022 19

CLINICAL | INFECTIOUS DISEASES

Healthcare providers are key to reducing cervical cancer

HPV vaccination is cancer prevention. Every year that adolescents aren’t vaccinated is another year they are left unprotected against cancer-causing infections. A clinician recommendation plays a critical role in getting parents to accept an HPV vaccination for their child.

C

ENTERS FOR DISEASE CONTROL and Prevention is encouraging practitioners to make an effective recommendation for HPV vaccination for all 11- 12-year-old patients.

CANCER RISK REDUCTIONS The introduction of an HPV immunisation programme in England substantially reduced cases of cervical cancer and incidence of grade 3 cervical intraepithelial

neoplasia (CIN3) in young women, particularly those who received the vaccine at the age of 12 or 13, researchers found.

START THE CONVERSATION

You could help prevent certain HPV-related cancers and disease 1 Encourage all your eligible male and female patients to GET VACCINATED HPV infections are the most common STIs 1

FEMALE 9-45 years of age 2

Most sexually active people will have an asymptomatic HPV infection at some time 1

MALE 9-26 years of age 2

Persistent HPV infection can lead to certain HPV-related cancers and diseases in men and women 1

EVERY ONE COUNTS

FOR ADVERSE EVENTS, PRODUCT QUALITY OR MEDICAL INQUIRIES, PLEASE CONTACT dpoc_zaf@merck.com SELECTED SAFETY INFORMATION: INDICATIONS: GARDASIL is a vaccine indicated in girls and women 9 through 45 years for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts and infections caused by the Human Papillomavirus (HPV). GARDASIL is indicated in boys and men 9 through 26 years of age for the prevention of external genital lesions and infection and the following diseases caused by HPV types included in the vaccine CONTRA-INDICATIONS: Hypersensitivity to the active substances or to any of the excipients of the vaccine. Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of GARDASIL should not receive further doses of GARDASIL. WARNINGS AND SPECIAL PRECAUTIONS: This vaccine should not be used interchangeably with other Human Papillomavirus (HPV) vaccines (as such use has not been studied). This vaccine should be given with caution to individuals with either thrombocytopenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals. Appropriate medical treatment should always be readily available in case of anaphylactic reactions following the administration of GARDASIL.

BEFORE ADMINISTERING GARDASIL, PLEASE CONSULT THE FULL PACKAGE INSERT.

Learn more about why prevention matters for your male and female patients REFERENCES: 1. Elissa Meites, et al. Human Papillomavirus. Centers for disease control and prevention. Oct 2020; 175-188.

2. GARDASIL approved Package Insert, 25 March 2015.

MSD (Pty) Ltd (Reg. No. 1996/003791/07) I Private Bag 3, Halfway House 1685 I 011 655 3000 I www.msd.co.za S2 GARDASIL® – Reg. No: 41/30.1/0145. Each 0,5 ml dose contains approximately 20 microgram of Human Papillomavirus (HPV) 6 L1 protein, 40 microgram of HPV 11 L1 protein, 40 microgram of HPV 16 L1 protein, and 20 microgram of HPV 18 L1. Copyright © 2022 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. All rights reserved. ZA-HPV-00054 04/24

In their register-based population study, estimated relative reductions in cervical cancer rates were 87% for those offered vaccination at ages 12 to 13, 62% at ages 14 to 16 and 34% at ages 16 to 18 compared with reference unvaccinated cohorts, reported Guy's Cancer Centre in London. Similar estimated risk reductions were observed for the incidence of CIN3: 97% at ages 12 to 13, 75% at ages 14 to 16, and 39% at ages 16 to 18, noted The Lancet. Compared with the unvaccinated population, Sasieni and colleagues estimated that there were 448 fewer cases of cervical cancer than expected and 17 235 fewer cases of CIN3 than expected in the vaccinated cohort by June 30, 2019.

These results mirror those from a Swedish study that estimated that HPV vaccination reduced the chances of developing invasive cervical cancer by 88% over an 11-year period.

CONCLUSION The problem of uptake is more pronounced in low- and middle-income countries where cervical cancer is a public health issue of particular concern. The most important issue, besides the availability of the vaccine, is the education of the population to accept the vaccination because a high rate of immunisation is a key element of success.

Healthcare providers should introduce the HPV vaccine and address HPV vaccine hesitant parents’ concerns.

Sources: MedPage Today, The Lancet, Centers for Disease Control and Prevention.

20 May 2022 | MEDICAL CHRONICLE

CLINICAL | CARDIAC

Strategies to manage VTE

In this article Prof James Ker introduces us to haemodynamically stable venous thromboembolism.

Next issue, he examines strategies to manage the condition.

V

ENOUS THROMBOEMBOLISM (VTE), consisting of deep venous thrombosis (DVT), and pulmonary embolism (PE), affects about 10 million people globally with an annual incidence of 1-2 cases per 1000 of the population and this incidence rises with increasing age.1 Globally, acute VTE is the third most common acute cardiovascular syndrome after acute myocardial infarction and stroke.2 VTE events can occur up to 50% in patients during or shortly after hospitalisation.3 About 10% of all hospitalassociated deaths are associated with VTE. About one third of all patients with a VTE event will have a recurrence of the VTE event within the next 10 years.3 There are some indications that the incidence of inhospital deaths due to VTE are declining.

the innate immune cells.

RISK FACTORS FOR VENOUS THROMBOEMBOLISM1,2 Strong risk factors that are persistent: • Active cancer • Antiphospholipid syndrome.

Strong risk factors that are transient:

• Major surgery of longer than 30 minutes • Major trauma or fracture • Joint replacement and spinal cord surgery • Caesarean section • Hospitalisation for acute illness and prolonged immobility (longer than three days).

Weak risk factors that are persistent include chronic inflammatory conditions,

CONSEQUENCES OF VTE There is an increased risk of death during the acute episode of VTE. About 20% of patients with a VTE event will die within a year after diagnosis, often of an underlying co-morbidity.

1. Major bleeding associated with anticoagulant therapy 2. Post-thrombotic syndrome such as postphlebitic leg with venous insufficiency 3. Post-embolism syndrome, such as chronic thromboembolic hypertension and persisting functional limitations such as dyspnoea and poor physical performance and a reduced quality of life 4. Large healthcare economic burden.

Prof James Ker

infection, obesity, nursing home confinement, personal positive family history of VTE, oestrogen therapy, minor trauma or fracture, pacemaker placement, pregnancy or puerperium, surgery less than 30 minutes, blood transfusion and platelet transfusion.

References available on request.

Protection never rests

The above consequences indicate the necessity of early diagnosis of VTE and adequate early treatment.

PATHOPHYSIOLOGY VTE is a multicausal complex disease triggered by provoking factors. Provoking or risk factors are traditionally associated with Virchow’s triad consisting of conditions of stasis, hypercoagubility, and abnormalities of the blood vessel. VTE is also now regarded as a cardiovascular continuum in which the traditional cardiovascular risk factors for atherosclerotic disease also increase the risk of VTE.4 The proposed mechanism for the development of venous thrombosis is a complex interaction between coagulation and inflammation in which activating the coagulation cascade stimulates the immune system and in turn, innate immune cells then contribute to thrombus formation in a process called immunothrombosis.5 Leucocytes are the primary source of procoagulant tissue factor-positive microparticles that stimulate thrombus formation and growth. Neutrophils produce neutrophil extracellular traps (NETs) that provide a scaffold for red cells, platelets and procoagulant molecules to promote thrombus formation. Platelets help induce the formation of NETs and augment the procoagulant activity of

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REFERENCES: 1. Registered XARELTO® 10, XARELTO® 15 and XARELTO® 20 Professional Information (PI) insert of South Africa. 2. IQVIA MIDAS. Database Quarterly Sales Q1 2021 [Data on file].

XARELTO® 10 (Rivaroxaban 10 mg): South Africa: S4 Reg. No.: 42/8.2/1046; Namibia: NS2 10/8.2/0463; Botswana: S2 BOT1302278; Zimbabwe: PP10 Reg. 2017/10.2/5362; Mauritius: R12697/02/14.

XARELTO® 15 (Rivaroxaban 15 mg): South Africa: S4 Reg. No.: 46/8.2/0111; Namibia: NS2 12/8.2/0006; Botswana: S2 BOT1302296; Zimbabwe: PP10 Reg. 2017/10.2/5363; Mauritius: R11772/02/14.

XARELTO® 20 (Rivaroxaban 20 mg): South Africa: S4 Reg. No.: 46/8.2/0112; Namibia: NS2 12/8.2/0007; Botswana: S2 BOT1302297; Zimbabwe: PP10 Reg. 2017/10.2/5364; Mauritius: R12698/02/14.

Applicant/HCR: Bayer (Pty) Ltd, Co. Reg. No.: 1968/011192/07, 27 Wrench Road, Isando, 1609. Tel: 011 921 5044 Fax: 011 921 5041

PP-XAR-ZA-0223-1 © Bayer (Pty) Ltd, March 2022

Xarelto 10

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MEDICAL CHRONICLE | May 2022 21

CLINICAL | ASTHMA

Addition of LAMAs in asthma control The updated guidelines GINA and SATS now include addition of long-acting muscarinic antagonists (LAMAs) in steps 4 and 5.

O

NE OF THE key messages of the latest version of the South African Thoracic Society (SATS) guideline is to incorporate the use of a LAMA in combination with inhaled corticosteroid long-acting beta2-agonist (ICS-LABA).

LAMAs LAMAs are recommended as monotherapy for patients with moderate COPD. In

asthma, when added to maintenance treatment with ICS alone or ICS/LABA, they improve lung function and may reduce the risk of exacerbations. Their effect on asthma symptoms is less consistent. They should be considered in patients who are uncontrolled on medium- to high-dose ICS-LABA. There are currently no data to guide the clinician’s decision on whether to add a LAMA or ‘step up’ to a higher dose of ICS

in a patient uncontrolled on medium ICSLABA. Prescription of a LAMA should be considered in patients who are uncontrolled on high-dose ICS-LABA. GINA’S GUIDANCE The Global Initiative for Asthma Strategy 2021 includes add-on LAMAs. Step 5 recommendations for add-on LAMA have been expanded to include combination

ICS-LABA-LAMA, if asthma is persistently uncontrolled despite ICS-LABA. • Add-on tiotropium in separate inhaler (ages ≥6 years) • Triple combinations (ages ≥18 years): beclometasone-formoterolglycopyrronium; fluticasone furoatevilanterol-umeclidinium; mometasoneindacaterol-glycopyrronium.

Adding a LAMA to medium or high dose ICS-LABA modestly improves lung function but not symptoms. In some studies, an add-on LAMA modestly increased the time to severe exacerbation requiring oral corticosteroids. For patients with exacerbations, it is important to ensure that the patient receives sufficient ICS, ie at least medium dose ICS-LABA, before considering adding a LAMA. TAKE-HOME MESSAGES Take-home messages from SATS guidance include: • SA has one of the highest reported asthma mortality rates, despite availability of ICS in all sectors of the healthcare system • Patients with so-called ‘mild’ asthma are at risk for acute exacerbations and death, and should have an ICS included in their management strategy • Early diagnosis and control of asthma will reduce morbidity and mortality, and most people with asthma can lead a normal life with optimal control • Long-term use of oral corticosteroids is strongly discouraged owing to their severe side-effect profile • Inhaler technique and adherence must be addressed at every consultation before making any change in drug therapy. Poor technique is one of the most common causes of poor asthma control • Lung function should be measured annually in patients with asthma to objectively measure lung function impairment. At each clinic visit, a simple and validated scoring method such as the Asthma Control Test (ACT) should be used to determine current asthma control • Where possible, patient preference should be considered in the selection of inhaler device (dry powder or pressurised metered dose inhaler (pMDI)). Adequate instruction in inhaler technique is essential and should be checked at every visit • Well-controlled asthma does not appear to be a risk factor for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (Covid-19).

Poor asthma control requiring the use of oral corticosteroids may increase the risk for Covid-19.

References available on request.

22 May 2022 | MEDICAL CHRONICLE

CLINICAL | MEN'S HEALTH

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CLINICAL | DIABETES

IDegLira vs basal-bolus insulin in T2DM

In patients with uncontrolled type 2 diabetes on basal insulin, prandial insulin may be initiated. Billings et al (2021) assessed the efficacy and safety of initiating insulin degludec/liraglutide fixed-ratio combination (IDegLira) vs basal-bolus insulin.

A

PHASE 3B TRIAL examined patients with uncontrolled type 2 diabetes mellitus (T2DM) on insulin glargine (IGlar U100) 20–50 units/day and metformin, randomised to IDegLira or IGlar U100 and insulin aspart (IAsp) four or fewer times per day.

RESULTS Glycated haemoglobin (HbA1c) decreased from 8.2% to 6.7% with IDegLira, and from 8.2% to 6.7% with basal-bolus (estimated treatment difference 20%), confirming IDegLira noninferiority vs basal-bolus.

The number of severe or blood glucoseconfirmed symptomatic hypoglycaemia events was lower with IDegLira versus basal-bolus. Body weight decreased with IDegLira and increased with basal-bolus (estimated treatment difference 23.6kg).

Fasting plasma glucose reductions were similar. Lunch, dinner and bedtime selfmonitored plasma glucose measurements were significantly lower with basal-bolus.

Sixty-six per cent of patients on IDegLira vs 67% on basal-bolus achieved HbA1c <7% (53mmol/mol). Total daily insulin dose was lower with IDegLira (40 units) than basal bolus (84 units total; 52 units basal).

BACKGROUND In the disease progression of T2DM, adequate blood glucose (BG) control with basal insulin may deteriorate over time. By the time basal insulin is initiated, patients, on average, have had a T2DM diagnosis for 9.2 years and a HbA1c level of 9.5% (80mmol/mol). In one study, only 29% of patients could maintain HbA1c <7% (53mmol/mol) three years after basal insulin initiation.

24 May 2022 | MEDICAL CHRONICLE

Current guidelines recommend therapy intensification if HbA1c targets are not reached after three-six months of basal insulin. However, many patients remain without therapy intensification due to concerns such as potential increased hypoglycaemia risk, weight gain and treatment complexity.

Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are incretin mimetics that lower fasting plasma glucose (FPG) and postprandial glucose via stimulation of endogenous insulin and inhibition of glucagon secretion, with weight-reducing effects through appetite suppression.

Using basal insulin with GLP-1RAs is a recognised therapeutic option after failure to achieve glycaemic control with basal insulin.

Comparison of basal insulin and GLP1RA given in separate injections vs basal insulin alone showed a significantly greater HbA1c reduction and weight loss with the combination therapy, with significantly more hypoglycaemic events.

Comparison with basal-bolus showed noninferior HbA1c reduction with basal insulin and GLP-1RA loose combination, and more desirable hypoglycaemia rates and weight management. This evidence supports combination therapies such as IDegLira, a fixed-ratio combination of insulin degludec (degludec) and liraglutide.

IDegLira efficacy and safety were established in the DUAL clinical trial programme in patients with uncontrolled T2DM on oral antidiabetic drugs (DUAL I, IV, and VI trials, GLP-1RAs (DUAL III trial, and basal insulin (DUAL II and V trial). This, the DUAL VII trial, then assessed IDegLira efficacy and safety vs basal-bolus.

PRIMARY ENDPOINT After 26 weeks of treatment, mean HbA1c decreased from 8.2% (66mmol/ mol) at baseline to 6.7% (50mmol/mol) at end of trial with IDegLira, and from 8.2% (67mmol/mol) to 6.7% (50mmol/mol) with basal bolus. The estimated treatment difference was 20.02% (95% CI 20.16, 0.12) (20.2mmol/mol [95% CI 21.7, 1.3]), confirming noninferiority of IDegLira vs basal-bolus. In total, 489 patients (244 and 245 in the IDegLira and basal-bolus arms, respectively) contributed to the primary analysis.

CONCLUSION This unique trial compares a fixed-ratio combination of basal insulin and GLP1RA with basal-bolus. With once-daily vs multiple daily injections, IDegLira was noninferior to basal-bolus in terms of HbA1c reduction and was statistically superior in a lower hypoglycaemia rate and change in bodyweight in patients on IGlar U100 and metformin with uncontrolled BG. Other trials have investigated combinations of insulin and GLP-1RA given separately.

In the BEGIN: VICTOZA ADD-ON trial, addition of liraglutide to degludec in separate injections resulted in a significantly greater reduction in HbA1c vs addition of IAsp at one meal to degludec, with weight loss and a reduced risk of hypoglycaemia.

The addition of once weekly albiglutide to IGlar U100 resulted in similar HbA1c reductions vs IGlar U100 and prandial insulin lispro, with weight loss and a reduced risk of hypoglycaemia.

These results are mirrored in this trial.

Furthermore, the fixed combination achieved these outcomes with only one injection per

day (vs five or fewer in the basal-bolus arm) and lower rates of nausea, likely attributable to the ability to slowly titrate the IDegLira dose in contrast to the separate injections.

An insulin-sparing effect was demonstrated with IDegLira vs basal-bolus.

Patients achieved similar HbA1c reductions with a mean daily dose of 13 units of basal insulin less with IDegLira and nearly 45 units of total daily insulin less.

Despite being an efficacious glucoselowering therapy, basal-bolus treatment is associated with a higher rate of hypoglycaemia vs other diabetes therapies.

Although resulting in similar HbA1c reductions, IDegLira was confirmed to be statistically superior to basal-bolus, with an 89% lower rate of severe or BG-confirmed symptomatic hypoglycaemic episodes and 92% lower rate in nocturnal hypoglycaemia.

The striking difference in the cumulative incidence of hypoglycaemia.

In patients with uncontrolled T2DM on IGlar U100 and metformin, IDegLira treatment elicited HbA1c reductions comparable to basal-bolus, with statistically superior lower hypoglycaemia rates and weight loss vs weight gain.

REFERENCE Billings LK, Agner BFR, Altuntas Y, et al. The Benefit of Insulin Degludec/Liraglutide (IDegLira) Compared with Basal-Bolus Insulin Therapy is Consistent Across Participant Subgroups with Type 2 Diabetes in the DUAL VII Randomized Trial. Journal of Diabetes Science and Technology. 2021;15(3):636-645. doi:10.1177/1932296820906888

Consider XULTOPHY ® for your patients not optimally controlled on multiple daily injections

NEW

Images shown are models, not real patients.

Reference: 1. Xultophy® Professional Information.

Scheduling status: S4 Name of the medicine: Xultophy®. Qualitative and quantitative composition: Each mℓ of solution contains 100 units insulin degludec and 3,6 mg liraglutide in a pre-filled pen. Therapeutic indications: Xultophy® is indicated for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control added to one or more oral hypoglycaemic medicines. Liraglutide, a component of Xultophy®, is indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus at high cardiovascular risk. However, the effectiveness of Xultophy® on reducing the risk of cardiovascular events in adults with type 2 diabetes mellitus has not been established. Posology and method of administration: Xultophy® is given once daily by subcutaneous administration and can be administered at any time of the day, preferably at the same time of the day. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis. Patients who forget a dose are advised to take it upon discovery and then resume their usual once-daily dosing schedule. A minimum of 8 hours between injections should always be ensured. This also applies when administration at the same time of the day is not possible. Xultophy® is to be dosed in accordance with the individual patient’s needs. It is recommended to optimise glycaemic control via dose adjustment based on fasting plasma glucose. Xultophy® is administered as dose steps. The pre-filled pen can provide from 1 up to 50 dose steps in one injection in increments of one dose step. The maximum daily dose is 50 dose steps. The starting dose of Xultophy® as add-on to oral anti-diabetes drugs (OADs) is 10 dose steps and 16 dose steps when transferring from GLP-1 receptor agonist or any insulin therapy regimen. Close glucose monitoring is recommended during the transfer and in the following weeks when transferring from either GLP-1 receptor agonist or any insulin therapy regimen. In elderly patients, in patients with mild, moderate or severe renal impairment and hepatic impairment, glucose monitoring should be intensified and the dose adjusted on an individual basis. Xultophy® cannot be recommended for use in patients with end-stage renal disease. Xultophy® is not to be used in children/adolescents. Contraindication: Hypersensitivity to either or both active substances, i.e. insulin degludec and liraglutide or to any of the excipients, Type 1 diabetes mellitus, diabetic ketoacidosis, pancreatitis, pregnancy and lactation. Special warnings and precautions for use: Xultophy® should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Too high dose, omission of a meal, or unplanned strenuous physical exercise may lead to hypoglycaemia. In combination with sulphonylurea, the risk of hypoglycaemia may be lowered by a reduction in the dose of sulphonylurea. Patients must be advised to take precautions to avoid hypoglycaemia while driving. Inadequate dosing and/or discontinuation of anti-diabetic treatment may lead to hyperglycaemia and potentially to hyperosmolar coma. Skin and subcutaneous tissue disorders: Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site from an affected to an unaffected area, and dose adjustment of antidiabetic medications may be considered. When using Xultophy® in combination with thiazolidinediones and insulin medicines, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Thiazolidinediones should be discontinued if any deterioration in cardiac symptoms occurs. Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, Xultophy® should be discontinued; if acute pancreatitis is confirmed, Xultophy® should not be restarted. In the absence of other signs and symptoms of acute pancreatitis, elevations in pancreatic enzymes alone are not predictive of acute pancreatitis. Thyroid adverse events, such as goitre has been reported in clinical trials with liraglutide and in particular in patients with pre-existing thyroid disease. Xultophy should therefore be used with caution in these patients. There is no experience with Xultophy® in patients with inflammatory bowel disease and diabetic gastroparesis. Xultophy® is not recommended in these patients. Signs and symptoms of dehydration, including renal impairment and acute renal failure, have been reported in clinical trials with GLP-1 receptor agonists including liraglutide. Patients must always check the pen label to avoid accidental mix-ups with other injectable diabetes medicinal products. Transfer to Xultophy® from doses of basal insulin <20 and >50 units has not been studied. There is no therapeutic experience in patients with congestive heart failure New York Heart Association (NYHA) class IV and Xultophy® is therefore not recommended for use in these patients. Interaction with other medicines and other forms of interaction: Substances that may reduce the Xultophy® requirement: Anti-diabetic products, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulphonamides. Substances that may increase the Xultophy® requirement: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormones and danazol. Beta-blockers may mask the symptoms of hypoglycaemia. Octreotide/lanreotide may either increase or decrease the Xultophy® requirement. Alcohol may intensify or reduce the hypoglycaemic effect of Xultophy®. Fertility, pregnancy and lactation: Xultophy® should not be used during pregnancy. If a patient becomes pregnant, treatment with Xultophy® should be discontinued. Xultophy® should not be used during breast-feeding. Undesirable effects: Hypoglycaemia, decreased appetite, nausea, diarrhoea, vomiting, constipation, dyspepsia, gastritis, abdominal pain, gastroesophageal reflux disease, abdominal distension, injection site reaction, urticaria, hypersensitivity, dehydration, eructation, flatulence, rash, pruritus, lipodystrophy and increased heart rate, anaphylactic reaction, pancreatitis, peripheral oedema, fatigue, cholelithiasis, cholecystitis, increased lipase and increased amylase. Post-marketing sources: cutaneous amyloidosis. Skin and subcutaneous tissue disorders: Lipodystrophy (including lipohypertrophy, lipoatrophy) and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions Increased heart rate: In the LEADER trial, no long-term clinical impact of increased heart rate on the risk of cardiovascular events was observed with liraglutide (a component of Xultophy). Overdose: Hypoglycaemia may develop if a patient is dosed with more Xultophy® than required: Mild hypoglycaemic episodes can be treated by oral administration of glucose or other products containing sugar. Severe hypoglycaemic episodes, where the patient is not able to treat himself, can be treated with glucagon (0,5 to 1 mg) given intramuscularly or subcutaneously. Reg. No.: 50/21.13/0985 For full prescribing information, refer to the Professional Information approved by the Regulatory Authority.

Novo Nordisk (Pty) Ltd. Reg. No.: 1959/000833/07. 150 Rivonia Road, 10 Marion Street Office Park, Building C1, Sandton, Johannesburg, 2196.

Tel: (011) 202 0500 Fax: (011) 807 7989. www.novonordisk.com. 18765T. ZA22XUM00001 January 2022.

MEDICAL MEDICAL CHRONICLE CHRONICLE | February | March 2022 5

CLINICAL | CARDIAC

Objective risk assessments

in PAH optimise treatment As physicians we pride ourselves in using the latest available evidence to objectively assess and treat our patients, to obtain the best possible outcomes.

Y

ET, IN DOING SO, there is risk of neglecting the patient on the other side of the parameters.

Receiving a diagnosis of pulmonary artery hypertension (PAH) can be devastating to patients and families, a frustration that is often compounded by the ubiquitous delays in diagnosis, all the while symptoms progress. Misinformation abounds on the internet and social media platforms, and patients can initially be both fearful and overwhelmed, while at the same time feeling isolated.

It is important for us as clinicians to be aware of our individual patient’s perspective, recognising up to half may be experiencing depression. But the personal impact of PAH extends beyond depression, with 60% reporting a major impact on overall quality of life, and 90% reporting at least some concerns about life-expectancy, while 73% report reductions in household incomes. This impact is not limited to the

patients, with 29% of carers also reporting negative effects on their employment. As doctors, we need to take steps to identify each patient’s 'extra-medical' needs and take steps to address these. Dr Howard emphasises in the second article, two key steps namely, empowering our patients through providing correct information and shared decision making, and directing our patients towards reputable patient associations and support groups. Each patient has unique expectations of their care, but improvement in overall quality of life and increased life expectancy are valued as 'most important' for the majority.

Fortunately, the hopelessness of previous generations can now be dispelled. With appropriate assessment and management, improved outcomes are possible for most patients. Better understanding of the pathophysiology of PAH and availability of therapy combinations have driven these advances.

4985M PAH Non Prescriber Banner Ad MC 215x76mm FA.indd 1

26 May 2022 | MEDICAL CHRONICLE

Prof Hoeper, of the Hannover Medical School, Germany, emphasises the importance of regular, objective risk assessments in PAH, highlighting the importance of aiming for low-risk criteria in patients. Large prospective registry data has confirmed that this can now be effectively assessed non-invasively. Two metaanalyses have shown that dual therapy reduces the risk of clinical worsening over mono-therapy by approximately 30%, both overall and in connective tissue disease (CTD) associated PAH. These data are encouraging, and Prof Hoeper explores the use of dual therapy further in his article.

PAH is not an easy burden for patients to carry, and we as clinicians, therefore, need to frequently reassess our patients with PAH to optimise treatment and maximise outcomes, while using these important patient interactions to encourage, educate, understand and assist as best we can with their 'extra-medical' needs.

Prof Brian Allwood Associate Professor Division of Pulmonology Stellenbosch University Stellenbosch

*Supplied content

HOW TO ASSESS RISK AND OPTIMISE TREATMENT IN PATIENTS WITH PAH Marius Hoeper, Hannover Medical School, Hannover, Germany This article is from the abstract: The lung, at the heart of pulmonary arterial hypertension, presented at: Janssen-sponsored Industry Evening Symposium, 30th European Respiratory Society International Congress, 9 September 2020.

The importance of comprehensive, multiparameter risk assessment in the management of PAH has continued to increase over the last decade. The prognostic information gained from regular risk assessment provides information about the patient’s disease course and guides individualised treatment decisions, with the overall goal of keeping the risk of mortality low. There have been numerous methods proposed for assessing risk, including

2022/03/03 11:20

CLINICAL | CARDIAC the REVEAL risk score calculator and the risk stratified approach in the ESC/ ERS 2015 Guidelines. The latter approach, developed based on expert opinion and clinical evidence, stratifies patients into categories reflecting low-, intermediateand high-risk of one-year mortality based on multiple parameters. These parameters address clinical signs of disease progression, functional and exercise capacity, and measures of right ventricular function. It is recommended that patients are assessed at baseline and at regular follow-up intervals, every 3-6 months during the course of therapy, which allows tailored treatment decisions and early intensification of therapy to ensure that each patients gets the best possible outcome.

COMPERA, SPAHR and the French PH registry are three European registries that have recently been used to validate the risk assessment approach proposed in the ESC/ERS 2015 Guidelines. The prognostic relevance of risk stratification in over 3 000 incident patients was examined in these studies. An increased number of low-risk criteria, or a low-risk status, was associated with a significant survival advantage. This was observed at baseline and was even more pronounced at follow-up. Moreover, a noninvasive approach to risk assessment using only World Health Organization functional class (WHO FC), six-minute walking distance (6MWD) and (NTpro-)BNP has shown to be also very effective at baseline and follow-up, and has been validated also in the COMPERA registry. Furthermore, inclusion of immutable risk factors such age, sex and PAH aetiology in REVEAL 2.0 risk assessment has demonstrated prognostic value for long-term survival and can be used to guide the initial treatment decision.

The primary goal of PAH-specific treatment is to achieve and maintain a low-risk status. For those patients who are diagnosed at low- or intermediate-risk of mortality, initial oral combination therapy is strongly recommended by the 6th WSPH. Recent studies provide compelling evidence of improved long-term outcomes with double oral combination compared with monotherapy. For example, intensification to combination with macitentan improves health-related quality of life, exercise capacity and haemodynamics in PAH patients previously treated with phosphodiesterase type 5 inhibitors (PDE5i). However, for a small subset of patients including those for example with suspicion or high probability of pulmonary venoocclusive disease or pulmonary capillary haemangiomatosis, monotherapy is still recommended as an initial treatment choice.

In AMBITION, a randomised, controlled, multicentre study, a reduction in the risk of clinical failure was observed for patients receiving initial double combination therapy with an endothelin receptor antagonist (ERA) and a PDE-5i compared with patients receiving mono therapy, even when patients’ symptoms were less severe at baseline (WHO FC II). Moreover, results from the OPTIMA study show that initial combination therapy of macitentan and tadalafil improves the number of low-risk criteria

after 16 weeks of treatment while improving haemodynamics and exercise capacity compared to baseline. More recently, data from the randomised controlled study TRITON, evaluating whether initial oral triple was superior to initial oral double combination therapy in treatment-naïve patients, showed improvements in haemodynamics, NT-proBNP and functional capacity in both treatment groups, confirming the importance of combination therapy in PAH. Although the primary endpoint of the study was not met, the initial triple combination group of macitentan, tadalafil and selexipag showed positive signals

towards improved long-term outcomes.

These data support what was already observed in the GRIPHON study, showing that the addition of selexipag to patients already treated with a PDE-5i and an ERA reduced the risk of morbidity/ mortality events (by 37% compared to placebo), which seem to be even more pronounced when selexipag was added earlier in the course of the disease. The GRIPHON study, the largest randomised controlled study investigating the effects of selexipag on long-term outcomes in patients with PAH, suggested selexipag-treated patients, when compared to placebo, were more likely to increase their number of low-risk criteria

from baseline. In conclusion, the use of initial double combination therapy for most PAH patients is strongly supported by clinical trial data and the recent WSPH 2018 Proceedings. This treatment approach has improved the outcomes of many patients, and escalation of treatment at the first sign of intermediate risk, earlier on in the course of the disease improves outcomes further.

REFERENCE Allwood B, Hoeper M. in PHocus. Latest developments in the management of Pulmonary Hypertension. Issue 3:2021:3;12.

Spotting pulmonary arterial hypertension (PAH) early is key to changing your patient’s outcome.1 Symptoms like chest pain, dyspnoea & syncope could be a warning sign of this deadly disease.2,3 Get clarity. Check. Refer. Before time runs out.

Visit the Janssen Medical Cloud for more information PAH, Pulmonary arterial hypertension 1. National Pulmonary Hypertension Centres of the UK and Ireland. Heart 2008; 94:i1–i41. 2. Galiè N et al. Eur Heart J 2016; 37:67–119. 3. Humbert M et al. Eur Respir Rev 2012; 21:306–312.

JANSSEN PHARMACEUTICA (PTY) LTD/(EDMS) BPK; (REG. NO./REGNR. 1980/011122/07), No. 2, Medical Road, Halfway House, Midrand, 1685. www.janssen.com.

Medical Info Line: 0860 11 11 17. EM-75618. November 2021.

4985M Janssen PAH non-prescriber A4 Ad MC EM-75618 FA.indd 1

2022/03/03 11:09

MEDICAL CHRONICLE | May 2022 27

CLINICAL | BLEEDING DISORDERS

How to distinguish AHA

Acquired bleeding disorders can accompany haematological, neoplastic, autoimmune, cardiovascular or liver diseases, but can sometimes also arise spontaneously.

T

HEY CAN MANIFEST as single factor deficiencies or as complex haemostatic abnormalities. The following article addresses acquired haemophilia A, an autoimmune disorder characterised by inhibitory autoantibodies against coagulation factor VIII, and is based on an article recently published in Haemophilia: The Official Journal of the

World Federation of Haemophilia.

Patients with acquired bleeding disorders are often not seen first by haematologists or experts in bleeding disorders but rather by GPs, emergency or intensive care unit specialists, surgeons or any other specialty related to the site of first bleeding. For these physicians, it is often difficult to recognise a bleed as a

first symptom of what truly is a bleeding disorder. Firstly, because the bleed may not seem unusual. Laboratory tests would probably be done only if bleeds occurred without identifiable cause, were difficult to control, or frequently recurring. Secondly, if laboratory tests have been ordered, their interpretation can be challenging because abnormalities may sometimes indicate a

ACQUIRED HAEMOPHILIA (AH) BE AWARE OF THE SYMPTOMS OF A BLEEDING EPISODE DUE TO AH

Bleeding into the skin (purpura) and soft tissues1

! !

• AH is often associated with other autoimmune conditions, malignant disease, certain drugs and pregnancy1

!

Gastrointestinal bleeding1

Prolonged postpartum bleeding1

• AH is a potentially life threatening condition with mortality in range of 8-22%1

!

• Urgent Laboratory diagnosis is required when unexplained bleeding or bruising occurs.2

Haematuria1

Consider AH in patients with: Recent onset of abnormal bleeding, isolated prolongation in aPTT, Normal PT.2

TREAT ACCORDINGLY

Stop the bleed with NovoSeven®3

NovoSeven® is easy to use, convenient and portable with few reconstitution steps5 Con

12

90 µg/kg NovoSeven®

Full administration in 2–5 minutes5 Peak coagulation ability in 10 minutes6

every

9

2-3

hours 6

28 May 2022 | MEDICAL CHRONICLE

12

Until clinical haemostasis 3 is achieved4

every

9

4-12 hours 6

Successively increase dose interval to 4,6,8 or 12 hours 3 for as long as treatment is judged to be indicated4

haemostasis disorder, but more often result from underlying disorders, medications, the bleed itself or poor sample quality.

Even more confusing for non-experts, laboratory abnormalities such as a prolonged activated partial thromboplastin time (APTT) may indicate a bleeding disorder (eg deficiency in factor VIII, IX or XI), a thrombogenic state (eg lupus anticoagulant) or neither of the two (eg deficiency in factor XII, prekallikrein or high molecular weight kininogen). Patients with liver disease, despite presenting with low platelet counts or a prolonged prothrombin time (PT) may eventually have a greater risk of thrombosis than a risk to bleed. While the fact that laboratory tests can’t predict bleeding has resulted in recommendations against routine testing in the general population, it is still important to raise awareness about the most important acquired bleeding disorders and to guide physicians towards proper interpretation of laboratory results in different clinical scenarios.

EPIDEMIOLOGY Acquired haemophilia A (AHA) is a rare disorder. The UK surveillance study estimated in 2007 an incidence of 1.4 cases per million inhabitants per year. More recent estimates from Germany indicated an increase to up to six per million per year, possibly due to increased awareness of the disorder. Acquired haemophilia A affects men and women of all ages but is more frequent in the elderly. The mean age at diagnosis is approximately 70 years. About 30%-50% of patients have associated disorders, most often other autoimmune disorders or malignancy. About 5% of AHA cases occur in relation to pregnancy, usually postpartum. Due to its rarity, the disorder occurs almost always unexpectedly and is often not recognised.

PATHOPHYSIOLOGY AHA is due to neutralising autoantibodies against factor VIII (FVIII). The residual FVIII activity is <1IU/dL in 50% of patients (<5IU/ dL in 75%, <40IU/dL in 100%).

FVIII-binding antibodies are often of the IgG4 subclass (>90% of patients), but other IgG subclasses, IgM and IgA can occur in various combinations. The differential impact of isotypes and subclasses to FVIII neutralisation is not known. The anti-FVIII antibody response is usually polyclonal in nature, and different FVIII domains are involved. The role of associated disorders in the pathophysiology of the anti-FVIII immune response is unknown. A mystery is also the striking difference in bleeding phenotype between AHA and congenital haemophilia A (HA) or HA with inhibitors against FVIII (HA-I). Patients with AHA frequently suffer from cutaneous and deep muscle bleeds, whereas joint bleeds are rarely seen.

CLINICAL | BLEEDING DISORDERS DIAGNOSIS An isolated prolongation of the APTT (with normal PT) in a bleeding patient is the hallmark of AHA. Although APTT prolongation may result from many causes, it should never remain unexplained if observed in bleeding patients or before interventions with a high risk of bleeding.

In patients with AHA, FVIII activity will be found reduced, and the disorder is confirmed then by demonstrating the neutralising capacity of the autoantibody in the Bethesda assay. If FVIII activity testing and the Bethesda assay are not immediately available, an APTT mixing study may help to demonstrate the presence of an inhibitor in the patient plasma, which is at least suggestive of AHA in a bleeding patient. The mix of patient and normal plasma is recommended to be tested both immediately (a prolongation here would be suggestive of heparin or the lupus anticoagulant) and after incubation at 37°C for two hours (a progressive prolongation would be suggestive of inhibitors in AHA).

The differential diagnosis of an isolated APTT prolongation includes the following: • Low FVIII (AHA, HA, HA-I, von Willebrand disease (VWD) or AVWS) • Low factor IX (haemophilia B) • Low factor XI (historically also called haemophilia C) • Conditions not associated with bleeding (eg LA, low factor XII, PKK, HMWK) • Pharmacological anticoagulants (eg heparin, dabigatran).

AHA and lupus anticoagulant (LA) are sometimes difficult to differentiate.

Depending on its strength and the reagent used, LA can prolong the APTT to a variable degree and sometimes even interfere with APTT-based factor assays, including FVIII. AHA can be excluded in this situation by demonstrating normal FVIII activity in chromogenic substrate assay or absence of FVIII-binding antibodies in immunoassays. Note that AHA and LA are both autoimmune disorders and can occur simultaneously in patients. Acquired von Willebrand syndrome is usually simple to differentiate from AHA, because the APTT mixing study and the Bethesda assay will be negative. FVIII is usually only low in acquired von Willebrand syndrome, if von Willebrand factor antigen assays are also low.

TREATMENT Haemostatic therapy Patients with AHA should be referred to expert centres. At least, expert advice should be sought if referral is not possible. Surgical interventions can be life-threatening in patients with AHA and should be strictly avoided until haemostasis is secured by adequate treatment. The decision to treat bleeds, and the monitoring of treatment success, is based on clinical decision-making.

Clinically relevant bleeds are treated with bypassing agents (recombinant factor VIIa [rFVIIa, eptacog alfa activated], activated prothrombin complex concentrate [APCC])

or recombinant porcine factor VIII (rpFVIII, susoctocog alfa). Human FVIII concentrates are only recommended if other options are not available because their efficacy is lower than that of the bypassing agents.

Tranexamic acid can be used as an adjunct agent, for mucocutaneous bleeds, or as a single agent for minor bleeds. If rpFVIII is used, monitoring of the FVIII activity (by APTT-based one-stage assays) should be used to guide dosing. Such monitoring may help to prevent unnecessary and potentially harmful overdosing and to recognise patients with cross-reacting antibodies.

Such antibodies were found in 44% of patients (usually of low titre) and will require higher doses of rpFVIII.

Immunosuppressive therapy Immunosuppression is recommended to eradicate autoantibodies and induce remission of AHA. Regimens include corticosteroids (eg prednisone or prednisolone 1mg/kg body weight), rituximab (eg 375mg/m2 body surface area weekly for up to four doses) and/or cyclophosphamide (1-2mg/kg body weight daily). Caution should be exercised with old and fragile patients as registries show that mortality due to infection exceeds by far the risk of fatal bleeding.

Prognostic factors have been determined in an observational registry and may be helpful to guide immunosuppressive therapy in the future.

CONCLUSION Acquired bleeding disorders can be part of the pathophysiology of many diseases, including cardiovascular, hepatic, autoimmune and malignant disorders.

Recognition of symptoms and laboratory signs is key to identification and proper management. The field is rapidly moving and, therefore, close cooperation is required among all specialties involved in patient management, including experts in haemostasis and thrombosis.

REFERENCE Tiede, A, Zieger, B, Lisman, T. Acquired bleeding disorders. Haemophilia. 2021;27( suppl. 3):5–13. https://doi.org/10.1111/hae.14033.

References: 1) Giangrande P. Acquired Hemophilia. Revised ed. Montreal, Quebec, Canada: World Federation of Hemophilia; 2012. 2) Collins P, et al. BMC Res Notes 2010;3:161 3) Tengborn L et al.

BJOG 2012;119:1529 – 1537. 4) NovoSeven® approved professional information. 5) Maahs J et al. Mixing and administration times of bypassing agents: observations from the Dosing Observational Study in Hemophilia (DOSE). J Blood Med 2014;5:153-156. 6) Fernández-Bello I, et al. The pharmacokinetics and pharmacodynamics of single-dose and multiple-dose recombinant activated factor VII in patients with haemophilia A or B. Haemophilia 2017;23(1):868–876. .

NovoSeven® 1 mg, 2 mg & 5 mg abbreviated Professional Information Scheduling status: S4 Name of the medicine: NovoSeven® 1 mg, NovoSeven® 2 mg, NovoSeven® 5 mg; powder and solvent for solution for injection Qualitative and quantitative composition: NovoSeven® 1 mg (corresponds to 50 KIU) contains 1 mg per vial activated recombinant coagulation factor VIIa (eptacog alfa); NovoSeven® 2 mg (corresponds to 100 KIU) contains 2 mg per vial activated recombinant coagulation factor VIIa (eptacog alfa); NovoSeven® 5 mg (corresponds to 250 KIU) contains 5 mg per vial activated recombinant coagulation factor VIIa (eptacog alfa).

Therapeutic indications: • Treatment of patients with haemophilia with inhibitors to coagulation factor VIII and factor IX. The use of NovoSeven® is indicated for patients suffering life- or limb-threatening bleeds or requiring surgery and in home-treatment setting for early intervention to treat mild to moderate bleeding episodes.

• Treatment of bleeding episodes and for the prevention of bleeding in patients with congenital FVII deficiency undergoing surgery or invasive procedures.

• Treatment of bleeding episodes and for the prevention of bleeding in those patients undergoing surgery or invasive procedures with Glanzmann’s thrombasthenia with or without antibodies to GP IIb-IIIa and/or HLA, and with past or present refractoriness to platelet transfusions, or where platelets are not readily available.

• Treatment of bleeding episodes and for the prevention of bleeding in those patients with acquired haemophilia undergoing surgery or invasive procedures.

Posology and method of administration: Haemophilia A or B with inhibitors or expected to have a high anamnestic response: Mild to moderate bleeding episodes (including home therapy): Early intervention has been shown to be efficacious in the treatment of mild to moderate joint, muscle and mucocutaneous bleeds. Two dosing regimens can be recommended: 1) Two to three injections of 90 μg per kg body weight administered at three-hour intervals. If further treatment is required, one additional dose of 90 μg per kg body weight can be administered. 2) One single injection of 270 μg per kg body weight. The duration of the home therapy should not exceed 24 hours. There is no clinical experience with administration of a single dose of 270 μg per kg body weight in elderly patients. Serious bleeding episodes: An initial dose of 90 μg per kg body weight is recommended. Dosing frequency should initially be every second hour until clinical improvement is observed. If continued therapy is indicated, the dose interval can then be increased to 3 hours for 1 - 2 days. Thereafter, the dose interval can be increased successively to every 4, 6, 8 or 12 hours for as long as treatment is judged as being indicated. A major bleeding episode may be treated for 2 - 3 weeks but can be extended beyond this if clinically warranted. Surgery/ invasive procedure: An initial dose of 90 μg per kg body weight should be given immediately before the procedure. The dose should be repeated after 2 hours and then at 2 - 3 hour intervals for the first 24 - 48 hours depending on the surgery performed and the clinical status of the patient. In major surgery, the dose should be continued at 2 - 4 hour intervals for 6 - 7 days. The dose interval may then be increased to 6 - 8 hours for another 2 weeks of treatment. Patients undergoing major surgery may be treated for up to 2 - 3 weeks until healing has occurred.

Acquired Haemophilia: NovoSeven® should be given as early as possible after the start of a bleeding episode. The recommended initial dose, administered by intravenous bolus injection, is 90 μg per kg body weight. Following the initial dose of NovoSeven® further injections may be given if required. The duration of treatment and the interval between injections will vary with the severity of the haemorrhage, the invasive procedures or the surgery being performed. The initial dose interval should be 2 - 3 hours. Once haemostasis has been achieved, the dose interval can be increased successively to every 4, 6, 8 or 12 hours for as long as treatment is judged to be indicated.

Factor VII deficiency: The recommended dose range is 15 - 30 μg per kg body weight every 4 - 6 hours until haemostasis is achieved. Dose and frequency of injections should be adapted to each individual.

Limited clinical experience in long term prophylaxis in paediatric population has been gathered in the paediatric population below 12 years of age, with a severe clinical phenotype. Dose and frequency of injections for prophylaxis should be adapted to each individual.

Glanzmann’s thrombasthenia: The recommended dose is 90 μg (range 80 - 120 μg) per kg body weight at intervals of two hours (1,5 – 2,5 hours). At least three doses should be administered to secure effective haemostasis. The recommended route of administration is bolus injection as lack of efficacy may appear in connection with continuous infusion. For those patients who are not refractory, platelets are the first line treatment for Glanzmann’s thrombasthenia.

Contraindications: Hypersensitivity to the eptacog alfa, any of the excipients, or to mouse, hamster or bovine protein.

Special warnings and precautions for use: When NovoSeven® is administered to patients outside current approved indications, arterial thromboembolic events are common. There may be a potential risk of development of thrombotic events or induction of disseminated intravascular coagulation (DIC) in association with NovoSeven® treatment in patients receiving NovoSeven® after major surgery or in pathological conditions in which tissue factor may be expressed more extensively than considered normal. Because of the risk of thromboembolic complications, caution should be exercised when administering NovoSeven® to patients with a history of coronary heart disease, to patients with liver disease, to neonates, or to patients at risk of thromboembolic phenomena or disseminated intravascular coagulation. As NovoSeven® may contain trace amounts of mouse IgG, bovine IgG and other residual culture proteins, the remote possibility exists that patients treated with NovoSeven® may develop hypersensitivity to these proteins. In such cases treatment with antihistamines IV should be considered. The duration of home treatment should not exceed 24 hours. Patients with factor VII deficiency treated with NovoSeven® should be monitored for factor VII antibodies. One case of angioneurotic oedema has been reported spontaneously in a patient with Glanzmann’s thrombasthenia after administration of NovoSeven®. NovoSeven® contains less than 1 mmol sodium per injection, indicating that it is essentially “sodium free”. Contains sucrose.

Interaction with other medicines and other forms of interaction: The risk of a potential interaction between NovoSeven® and coagulation factor concentrates is unknown. Simultaneous use of prothrombin complex concentrates, activated or not, should be avoided. Anti-fibrinolytics have been reported to reduce blood loss in association with surgery in haemophilia patients, especially in orthopaedic surgery and surgery in regions rich in fibrinolytic activity, such as the oral cavity. Experience with concomitant administration of anti-fibrinolytics and NovoSeven® treatment is however limited.

Based on a non-clinical study it is not recommended to combine NovoSeven® and rFXIII. There are no clinical data available on interaction between rFVIIa and rFXIII. Fertility, pregnancy and lactation: It is not known whether NovoSeven® can affect reproduction capacity. Safety in pregnancy has not been established. As a precautionary measure, it is preferable to avoid the use of NovoSeven® during pregnancy. It is not known whether NovoSeven® is excreted in human breast milk.

Undesirable effects: Uncommon: venous thromboembolic events, rash, pruritus, urticaria, therapeutic response decreased, pyrexia; Rare: disseminated intravascular coagulation and related laboratory findings, coagulopathy, hypersensitivity, nausea, headache, arterial thromboembolic events, angina pectoris, injection site reaction including injection site pain, increased fibrin degradation products, increase of alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase and prothrombin levels; Frequency not known: anaphylactic reaction, intracardiac thrombus, flushing, angioedema.

Overdose: Dose limiting toxicities of NovoSeven® have not been investigated in clinical trials. Cases of overdose have been reported in patients with haemophilia. No cases of overdose have been reported in patients with acquired haemophilia or Glanzmann’s thrombasthenia. In patients with factor VII deficiency, one episode of overdose has been associated with a thrombotic event in an elderly (> 80 year) male patient treated with 10 – 20 times the recommended dose. In addition, the development of antibodies against NovoSeven® and FVII has been associated with overdose in one patient with factor VII deficiency. The dose schedule should not be intentionally increased above the recommended doses due to the absence of information on the additional risk that may be incurred. Treatment is symptomatic and supportive.

Reg. No.: NovoSeven® 1 mg: 44/8.1/0550, NovoSeven® 2 mg: 44/8.1/0551, NovoSeven® 5 mg: 44/8.1/0552 For full prescribing information, refer to the Professional Information approved by the Regulatory Authority. Text revision date by SAHPRA: 2021/11/08 Applicant Address: Novo Nordisk (Pty) Ltd, 150 Rivonia Road, 10 Marion Street Office Park, Building C1, Sandton, Johannesburg, 2196, South Africa. Tel: 011 202 0500 Fax: 011 807 7989

ZA21NS00008

MEDICAL CHRONICLE | May 2022 29

WEBINAR

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Is depression really a disease?

This webinar is sponsored by Dr Reddy's Date: 13 June 2022 Time: 6pm Presenter: Dr Lavinia Lumu Topic: Is depression really a disease?

Dr Lavinia Lumu,

Specialist Psychiatrist

CLICK TO REGISTER: https://bit.ly/DepressionWebinar13Jun22

Completed the fellowship in psychiatry and obtained the FCPsych (SA) qualification from the Colleges of Medicine in South Africa and a Master of Medicine in Psychiatry (Witwatersrand) in 2014. Currently in private practice with a special interest in perinatal psychiatry and currently running a pro-bono maternal mental health clinic at the Rahima Moosa Mother and Child

Hospital. An advocate for maternal mental health and supports the Grow Great - Flourish Foundation in maternal mental health training and also an executive board member of the International Marcé Society for Perinatal Mental Health. An honorary lecturer at the University of the Witwatersrand, Department of Psychiatry, Faculty of Health Sciences.

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Dr. Reddy’s Laboratories (Pty) Ltd. Reg no. 2002/014163/07. Block B, 204 Rivonia Road, Morningside, Sandton, 2057. www.drreddys.co.za. ZA/10/2020-22/CORP/031

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2022/03/16 10:35

CLINICAL | GASTROENTEROLOGY

Gut microbiome’s role in diseases The human gut microbiome (GM) is a huge microbial community that shows an irreplaceable role in human life.

T

HE FUNDAMENTAL MECHANISMS of GM on human diseases are incredibly difficult.

Recent studies focusses on regulation and mechanism of cardiovascular diseases, GM on neurodegenerative diseases, metabolic diseases and gastrointestinal diseases, providing a potential target for the prevention and treatment of disease.

The human gut microbiota is a dynamic and complex ecosystem inhabited by a myriad of microorganisms interrelating with each other and with the human host, including bacteria, archae, fungi and viruses. As the leading micro-ecosystem in the human body, GM is interdependent with the host and preserves normal physiological procedures in a dynamic equilibrium state.

In recent years, with the rapid development of molecular biology, bioinformatics analysis technology, genomics, and high throughput sequencing technology, the GM has made rapid progress. Evidence has shown GM disorder and its metabolites play a key role in maintaining host intestinal homeostasis and influencing the expansion of many diseases, including neurodegenerative diseases, metabolic diseases, cardiovascular diseases, and gastrointestinal diseases.

The imbalance of GM will affect the health of the host through many ways, such as energy absorption, short chain fatty acids, choline, gut-brain axis, bile acids, and so on. The association between GM and neurodegenerative disease has come to the attention of the medical community.

An increasing number of studies suggested that GM can modulate nervous, endocrine, and immune communication finished the gut-brain axis.

GM is closely connected to human health and diseases, which bring great occasions for the diagnosis, treatment and prevention of diseases.

Intestinal microbes are beneficial to disease treatment and promote overall immune health. The interactions between host immune systems, gut microbes, and diseases are not only complex but also highly dynamic. Presently, there are few effective methods for the treatment of clinical diseases by regulating intestinal flora. Aiming the composition and metabolic function of intestinal flora may be a new option for the prevention and treatment of diseases.

manipulation of intestinal microbial communities, suppression of pathogens, immunomodulation, stimulation of epithelial cell proliferation and differentiation and fortification of the intestinal barrier.

Probiotics have been proposed as preventive and therapeutic measures, in order to restore the healthy composition and function of the GM.

Metagenomic, metatranscriptomic and metabonomics can be deployed to globally examine interactions between probiotics, intestinal microbes and the mammalian gastrointestinal tract.

New types of probiotics or medicinal compounds derived from the microbiome may be used as future strategies to promote health, prevent disease, and treat

different disorders.

REFERENCES Farooq S. Significance of Gut Microbiome Role in Human Diseases. J Prob Health. 2022;10:255.

Hemarajata P, Versalovic J. Effects of probiotics on gut microbiota: mechanisms of intestinal immunomodulation and neuromodulation.

Therap Adv Gastroenterol. 2013;6(1):39-51. doi:10.1177/1756283X12459294.

PROBIOTICS Nobel laureate Elie Metchnikoff introduced the concept of probiotics to the scientific community. He published a seminal report linking the longevity of Bulgarians with consumption of fermented milk products containing viable Lactobacilli (Metchnikoff and Mitchell, 1907). This observation suggested that certain microbes, when ingested, could be beneficial for human health. Mechanisms of probiosis include MEDICAL CHRONICLE | May 2022 31

WEBINAR

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PCT informing antimicrobial stewardship?

This webinar is sponsored by Thermo Fisher Scientific Date: 25th May 2022 Time: 7pm Topic: PCT informing antimicrobial Stewardship?

Presenter: Fathima Paruk

Fathima Paruk

MBChB, FCOG, Cert Crit Care, MD (Natal) Full Professor In Critical Care

CLICK TO REGISTER: https://bit.ly/PCTwebinar25May22

Prof Fathima Paruk bio Key appointments 1. Critical Care Society of Southern Africa -President (current) -EXCO of Council and Honorary Secretary (2015-current) - Council Member (2009-current) 2. University of Witwatersrand, Human Research Ethics Committee (2011-current)) 3. University of Pretoria Human Research Ethics Committee (2016-2018) 4. Discovery Foundation Awards Screening Committee (2017-2021) 5. CMSA – Chair: Committee for Critical Care (2021-current) 6. Provincial Antimicrobial Stewardship Committee (2021-current) 7. University of Pretoria Finance Committee (1 term) 8. University of Pretoria: SOM Readmission Committee 9. University of Pretoria: SOM Postgraduate Program Committee 10.SBAH: Chair of SBAH Audit Committee 11.SBAH: Chair of Critical Care Committee

32 May 2022 | MEDICAL CHRONICLE

12. SBAH: Palliation Committee 13. Co-Chair: Africa Telehealth Collaboration (Current).

Ministerial appointments 1. HPCSA Medical and Dental Board (2016- 2025) - EXCO of MDB (2nd term, current) - Chairperson of the Chairs of Preliminary Enquiry Committee (2nd term, current) -Chair: Preliminary Enquiry committee 2 2. Postgraduate Education and Training (Committee (2016-2018) 3. National Health and Research Committee (2010-2015) 4. National Committee for Confidential Enquiries into Maternal Deaths (10 years/2 terms).

Achievements First obstetric intensivist in SA International Scientific Chair, World Federation Society of Intensive and Critical Care Medicine (WFSICCM) Congress 2013 International Scientific Advisory Committee member: WFSICCM 2015 (Seoul)

Trained 15 critical care subspecialists International lectures > 30 (Includes Plenary invitations) National lectures >220 PhDs,MMeD, MMSc: 15 graduates First publication (SAMJ) as an undergraduate (medical student) Intercontinental Tele-ICU Collaboration (Charite University and RKI).

Multiple research related awards including: - Young investigator Award (Canada) - MRC Research Fellowship - Faculty Research Day Award - Best oral paper awards Key opinion Leader (Critical Care) -Speaker bureaux of multiple (more than 15) local and international pharmaceutical organisations.

Over 100 publications: 70 in peer-reviewed journals/texts.

CLINICAL | DIGITAL THERAPEUTICS

App helps manage children's

mental health

Caring for a child with mental health or neurodiverse conditions is no easy task and healthcare providers (HCPs) and parents are reminded of that fact nearly every day.

H

CPs ARE HEAVILY reliant on the parents, teachers and caregivers to provide feedback about the child’s care progress, symptoms, behaviour and quality of life during the preceding six to 12 months. Due to the nature of reporting over extended periods, the reported information is often biased due to our human inability to accurately recall past events. In addition, HCPs seldom have an integrated view of a child’s holistic treatment plan, which often includes multiple clinicians and therapists.

Having this context is essential to support integrated care decision-making.

Although HCPs are typically open to introducing new tools in their practice, new tools are often incredibly expensive, overly complicated or do not support their current practice workflows – making the tools unpractical to adopt. As a parent caring for a child with attention deficit hyperactivity disorder (ADHD) or autism spectrum disorder (ASD) gives a whole new dimension to the usual parent responsibilities as both a caregiver and care coordinator. It is now widely acknowledged that living with ADHD or ASD in the immediate family can adversely impact the quality of life of the parents or caregivers. Following a threeyear collaboration with parents, teachers, clinicians and therapists, Augmental Technologies launched Tracto late last year, a companion app that empowers parents and HCPs caring for children with mental health conditions.

Tracto allows parents to invite teachers and caregivers to collaboratively track a child’s behaviours, symptoms and side effects over time. By giving the team around the child the opportunity to provide input, data is obtained from a wide circle of caregivers, allowing parents as well as HCPs to see the child’s behaviour and response to treatment through the eyes of others.

Now, both positive and negative behaviours can be captured, providing the healthcare provider with a complete view of the child’s symptoms and behaviour during the preceding months.

This offers an integrated and balanced input and allows a more robust assessment of the child’s overall mental health status.

Tracto allows parents and teachers to digitally complete clinically validated assessments within the app. Assessment results are instantly available and shareable with HCPs. Currently, only the SNAP-IV (ADHD) parent and teacher assessment is supported, however the team is continuously expanding the supported inapp assessments.

Treatment adherence also plays a key role in ensuring clinical outcomes, Tracto enables parent to configure reminders for medication and activities.

HELPING PROVIDERS HCPs do not have to install or use the app. They simply recommend parents to install the free Tracto app. Parents are able to easily share (email, WhatsApp) care progress reports with HCPs on request that

summarises a child’s integrated clinical picture in terms of symptoms, behaviour, side effects, and adherence to medication and activities. These reports are also easily uploaded to the HCP practice management software solution being used if needed.

Download the Parent Printout with an easy install QR code, which you can hand out to parents. For more information, visit www. tracto.app or email support@tracto.app.

Install the app for free: Apple App Store or Google Play Store.

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Empowering families caring for children living with ADHD For further product information contact PHARMA DYNAMICS Email info@pharmadynamics.co.za CUSTOMER CARE LINE +27 21 707 7000 ATTENCIT 10, 18, 25, 40, 60, 80 mg. Each capsule contains atomoxetine hydrochloride equivalent to 10, 18, 25, 40, 60, 80 mg atomoxetine respectively.

S5 A51/1.2/0376, 0377, 0378, 0379, 0380, 0381. For full prescribing information, refer to the professional information approved by SAHPRA, October 2020. RADD 18, 27, 36, 54 mg. Each prolonged-release tablet contains 18, 27, 36, 54 mg methylphenidate hydrochloride respectively. S6 A51/1.2/0289, 0290, 0291, 0292. For full prescribing information, refer to the professional information approved by SAHPRA, February 2021. NSCRA765/05/2022.

www.mydynamics.co.za

MEDICAL CHRONICLE | May 2022 33

CLINICAL | ONCOLOGY

The Evolution

of Genetics in Breast Cancer Dr Justus Apffelstaedt, specialist surgeon with an interest in breast, thyroid and parathyroid health as well as soft tissue surgical oncology.

Dr Justus Apffelstaedt Specialist surgeon

I

N 1990, THE now well-known BRCA 1 gene was sequenced, with the BRCA 2 gene to follow in 1994. In 2009, fullgene sequencing BRCA 1 and 2 became commercially available in South Africa.

On 14 May 2013, Angelina Jolie shared the news of her bilateral risk-reducing mastectomy (BRRM), based on her carrying a disease-causing BRCA1 mutation. This brought genetic risk assessment for breast cancer into mainstream consciousness.

We now have panel testing available for 84 genes associated with cancer risk. The development of these tests has provided specialists with an enhanced assessment for the risk of individuals to suffer a familial breast cancer.

In developing countries (including South Africa), genetic testing is becoming more common as it has become more affordable and accessible. Genetic testing is providing life-saving insights for whole families who often have seen several members succumb to this dreaded disease.

In Cape Town, a comprehensive breast centre has been using advanced genetic testing for risk assessment of healthy women and cancer patients alike.

Years of experience with the management of disease-causing BRCA gene mutations have shown, that after discussion of the different management strategies, most women choose their strategy based on their age: • Age 0 - 18: No action • Age 18 - 30: Surveillance: Annual breast imaging, ovarian cancer screening • Age 30 - 50: Active surgical risk management: Risk reduction mastectomies followed a couple of years later by risk-reduction ovariectomies • Age 50 - 70: Breast Imaging, ovariectomy • Age 70+: Clinical management.

As the evolution of gene testing continues, the information below documents some of the impressive uses of available genetic testing for diseasecausing mutations to showcase how genes can impact both breast cancer risk detection as well as the decisions regarding how individual cases should be managed.

The first example is the NBN gene. This gene provides instructions for making a protein called nibrin. This protein is involved in several critical cellular functions, including the repair of damaged DNA. Like all other well-known cancer genes, there is a 50/50 random chance to pass on a NBN mutation to your sons and daughters.

Everyone has two copies of the NBN gene. Mutations in one copy of the NBN gene can increase the chance for you to

34 May 2022 | MEDICAL CHRONICLE

In Cape Town, a comprehensive breast centre has been using advanced genetic testing for risk assessment of healthy women and cancer patients alike

develop certain types of cancer in your lifetime. Genetic testing for this gene usually takes place at the diagnosis of breast cancer if familial history shows multiple cancer cases at a young age. The treatment of the individual would be quite aggressive if this gene mutation is found at a young age; details will depend on the stage at which the cancer is diagnosed and the type of cancer.

As in other genes linked to an increased risk of breast cancer, a family work-up is imperative to put together risk reduction strategies for any other family members that carry the mutation.

Werner’s Syndrome is linked to another gene (the WRN gene) that also leads to an increased risk of suffering cancer. This syndrome is generally known as the ‘adult early aging’ disease, where accelerated aging takes place. Affected individuals have a short stature as well as other distinctive abnormalities such as lipodystrophy (a change in fatty tissue) and accelerated

atherosclerosis. As with all other cancercausing gene defects, defects in the WRN gene affect DNA repair negatively. Whilst a family might just be seen as ‘short’, if there is a high cancer incidence, it is very worthwhile requesting a panel test as this will include several cancer-related genes that might not be immediately obvious.

Another instructive example is one of a family with multiple breast cancers and a known BRCA 2 disease-causing mutation.

When one of the family members presented with a breast cancer, the obvious thought was that she also had inherited the family mutation. A prior colon cancer however raised suspicions and on testing the patient was found not to be carrier of the family mutation in the BRCA 2 gene but of a disease-causing mutation in the MUTYH gene. Defective MUTYH genes increase the risk of colon polyps and colorectal cancer as well as breast and other cancers. So, the breast cancer patient could also be

counselled concerning her specific cancer risk management strategies and her side of the family assessed. As can be seen, it is increasingly understood that gene testing in patients can provide hugely valuable information for treatment plans, risk management strategies for all cancers and can also, importantly, assist the family in understanding their own cancer vulnerabilities.

It is also becoming imperative that the treatment team should get as much information as possible about all cancers in the family, as that information can provide vital information that will guide which gene tests would be most useful.

Gene testing is constantly evolving and its role in breast cancer is becoming increasingly important. It gives medical professionals a new level of information from which to determine management options and ultimately, allows for a more individualised approach to cancer.

WEBINAR REPORT

HIV 2022: An update

Watch the replay here: https://event.webinarjam.com/ go/replay/400/ox64xu33synh28a0 Dr K.D. Mahomed (HIV Clinician) MBChB (Natal), DCH, DA, DIP HIV (SA)

This enlightening and important webinar was presented by HIV clinician Dr Kay Mahomed, of Netcare Garden City. This webinar hosted by Medical Chronicle and sponsored by Johnson&Johnson. The following article is based on Dr Mahomed’s presentation.

A

NTIRETROVIRAL TREATMENT (ART) is used for the treatment and prevention of HIV. In terms of the treatment of HIV, this is done with the aim of maximal suppression of viral replication (undetectable viral load [VL]), and the restoration of immune function (CD4 cell count). ART is life long and 100% adherence is essential. New drugs have lesser side effect and toxicity profile, and there is a good selection of drugs to fit into a patient’s profile, offering fixed-dose combination and daily dosing. For the prevention of HIV there is post-exposure prophylaxis (PEP) and preexposure prophylaxis (PrEP).

ANTIRETROVIRALS (ARVs) Therapy includes: • Nucleoside reverse transcriptase inhibitors (NRTI) • Non-nucleoside reverse transcriptase inhibitors (NNRTI) • Protease inhibitors (PI) • Integrase inhibitors • Fusion inhibitors • Entry inhibitors.

THERAPEUTIC STRATEGIES Always use three agents: • 2 NRTIs +1 NNRTI • 2NRTIs+1PI+low dose RTV • 2 NRTIs + 1 Integrase Inhibitor • 2 NRTIs + 1 Integrase Inhibitor + 1 PI + low dose RTV • 1 NNRTIs + 1 Integrase Inhibitor + 1 PI + low dose RTV. Triple therapy has a pronounced and prolonged Impact on VL. You can do a one-drug switch for side effects. You need to do a regimen change if there is no viral suppression.

NRTIs include: • Stavudine (d4T). Use Tenofovir (TDF) 3/12 if renal failure/ anaemia • Didanosine – no longer used • TDF. Tenofovir alafenamide (TAF) 25mg daily, has less renal and bone density side effects) • Zidovudine (AZT), if TDF contraindicated, no anaemia/ bone marrow failure • Abacavir (ABC).

If TDF contraindicated, watch VL: • Lamivudine (3TC) • Emtricitabine (FTC).

These are the backbone of highly active

antiretroviral therapy (HAART) drugs with high and low barriers to resistance. NRTIs inhibit viral reverse transcriptase enzyme, by incorporating into the newly developed chain of viral DNA competitively as building blocks.

NNRTIs • Nevirapine (NVP) – no longer used • Efavirenz (EFV) (be aware of breast abnormalities, hepatoxic and CNS symptoms) • Rilpivirine. Use cautiously in TB, monitor VL and be aware of ulcers.

These are part of the ‘first line’ of HAART cross-resistance ‘low genetic barrier’ to resistance (resistance develops rapidly). NNRTIs inhibit the viral reverse transcriptase enzyme: • Etravirine • Doravirine.

INTEGRASE INHIBITORS Raltegravir (RTG): • Fewer CNS adverse events than EFV • Drops VL quicker • Lower lipid levels • PEP • Has a low barrier to resistance.

Dolutegravir (DTG): • 50mg once daily • Double dose with RIF/EFV • Emtricitabine (FTC) with ABC/3TC requires human leukocyte antigen (HLA) testing • Take care with antacids • Increases metformin levels • Shift workers • DTG has a high barrier to resistance.

NEW REGIMEN OPTIONS Regimen 1: Strengths TEE: Previously used extensively. Can be used with TB TER: Fewer neurological side effects. Once daily dosing. Excellent for shift workers. No interaction with hormonal contraception. No teratogenicity. Keeping options open.

TLD: Rapid viral suppression high genetic barrier to resistance. Does not need initiation. Once daily dosing (AM). Excellent for shift workers. No food restriction. Can be used with TB (double dose DTG). No interaction with hormonal contraception).

Use in PEP.

Regimen 1: Caution TEE: Neuro-psychiatric s/e (pyschosis, bad dreams, insomnia, fatigue, drowsiness, dizziness and/or memory loss). Hepatoxic Gynaecomastia. Drug rash. Cannot use in shift workers.

TER: VL < 100,000Cannot be used with TB Ulcer drugs TLD: Weight gain Insomnia and agitation.

Diabetes (increases metformin levels).

Regimen 2: Strengths LPV/r: Can be used with RIF-based TB tx but must be double-dosed.

ATV/R: Co-combination of ATV 300 + Norvir100. Single tablet taken once a day, convenient dosing (previously 2/3 tablets) Better tolerated, adherence advantage. Low GIT side effects Better metabolic profile Dyslipidaemia significantly reduced two tablets once a day (Truvada/ Tarito, Dumiva/ Tarito). Can be taken at any time of the day.

Cost and convenience.

DRV/r: High genetic barrier to resistance.

Low GIT side effects. Can be used second and third line. No jaundice. Stanford scoring.

Regimen 2: Caution LPV/r: Pill size B.D dosing. Greater GIT side effects (diarrhoea, nausea, vomiting, abdominal pain, bloating). Worse metabolic profile. No dyslipidaemia.

ATV/r: Unconjugated hyper-bilirubinaemia, resulting in visible jaundice in a minority of patients. This does not indicate hepatic toxicity and is not a reason to discontinue the drug unless it is a worry to the patient for cosmetic reasons (reversible upon discontinuation). Cannot be used with RIF-based TB tx.

DRV/r: Cost 400 / 100, 800 / 100, 600 / 100 B.D Cannot use with RIF-based TB treatment.

PREVENTION PEP is used in cases of: • Exposure • Effective within 72 hours • Rapid • TLD can be given for one month and then retest.

PrEP is for: • HIV-negative patients who want to remain HIV negative • Rapid, creatinine, HepB, Elisa tests done, then can be put onto emtricitabine/

tenofovir • Can cycle on and off.

TAKE NOTE 1. Creatinine monitoring is important in all patients we see. This is because TDF has an effect on the kidneys.

2. VL monitoring is crucial. If the VL is undetectable, you are ensuring that the partner continues to remain negative, and babies are born HIV free.

3. TB is endemic in SA. Need to symptom screen for TB all the time. Ask patients about symptoms every time you see them – loss of appetite, loss of weight, night sweats, cough.

4. You can prevent TB in patients by giving them Isoniazid preventive therapy (IPT).

5. Be aware of the phenomenon of immune reconstitution inflammatory syndrome, especially in patients with a low CD4 count on TB treatment. They can get a lot worse before they get better.

6. In patients with low CD4 counts, we give them sulphamethoxazole, trimethoprim.

Don’t give this with ARVs. Start ARVs for a week or two and then start Purbac.

Monitor renal function and when CD4s have picked up, drop Purbac.

7. When switching patients from one regimen to another, you need to know what you are doing. Make sure that the viral loads are undetectable. If the VLs are detectable, adherence is the most important thing. If you still can’t get the VL down, you need to switch regimens.

8. Understand virological failure and do the right thing.

9. Keep in mind that lots of patients have hepatitis B. If you are taking patients off TDF, do a Hep B surface antigen test. If patients are positive, we need to keep the TDF. 10. In terms of pregnancy, all women on ARVs need to be virally undetectable.

For new patients who are HIV negative, we need to retest every three months, as 12% of women can seroconvert towards the end of pregnancy.

MEDICAL CHRONICLE | May 2022 35

WEBINAR REPORT

Exploring schizophrenia Psychiatrist Dr Eugene Allers recently presented an update on schizophrenia.

This event was made possible by Dr. Reddy’s.

To watch the replay and still earn a CPD point, go to: https://event.webinarjam.com/go/ replay/401/10wo0u59uyou0gh4. The following article is based on Dr Allers’ presentation.

Dr Eugene Allers Specialists Psychiatrist

"S

CHIZO’ MEANS SPLIT in Greek, while ‘phrene’ refers to mind, to describe fragmented thinking associated with the condition.

Schizophrenia models are grouped into three categories • Developmental • Drug induced • Genetic.

Lifetime prevalence of schizophrenia is approximately 0.4% worldwide.

Positive symptoms include delusions, hallucinations, and thought disorders.

Negative symptoms include anhedonia, avolition, social withdrawal and poverty of thought. Its aetiology is still poorly understood but the following play a role: • Dopamine • Glutamate • Multiple neurotransmitters and neuromodulators, including 5-hydroxytryptamine (5-HT) • Gamma-aminobutyric acid (GABA) • Glycine • D-serine • Neuroactive steroids.

PROGNOSIS The prognosis is very varied. Studies show the following disability rates: • 41% (Chestnut Lodge) • 91% (Columbia) • 39% (Vaillant) • 30% (Phipps) Dr Allers’ unit has a 25% disability rate in schizophrenic patients.

the brain, but also a metabolic disorder.

Many physical illnesses occur with increased frequency in patients with serious mental illness.

Mortality rates are higher across multiple causes of death. Patients with schizophrenia had consistently increased mortality rates compared to controls.

The increased burden of comorbidities is particularly high in younger patients.

Schizophrenia has a considerable negative impact on survival. In younger patients with schizophrenia the mortality risk may be up to 13 times greater than controls.

SUICIDE RISK The following criteria indicate an increased suicide risk: • Poor adherence to medication • Male • Previous suicide attempts • Higher education • Higher IQ • Living alone • Family history of depression • Paranoia • Agitation • Worthlessness • Hopelessness • Depression • Drug abuse (other than alcohol).

The following decrease suicide risk: • Hallucinations • Negative symptoms.

The following have no influence on risk: • Race • Religion • Divorce • Not being a parent • Unemployed • Coming from a broken home • Raised by a single parent • Alcohol abuse.

Schizophrenia is a progressive disease that worsens with repeated relapses.

DIAGNOSTIC CHALLENGES WITH SCHIZOPHRENIA The DSM III narrowed down the diagnosis of schizophrenia, however the DSM 5 placed it on the spectrum with affective disorders and bipolar disorder.

DETERMINANTS OF GOOD OUTCOME Determinants of good outcome that has been researched longer symptom duration, later age of onset, higher total PANNS score (patients are more ill), greater positive symptoms, fewer negative symptoms, higher general psychopathology scores, lower mood scores on HamD, positive employment status, and independent living.

Schizophrenia is not only a disorder of 36 May 2022 | MEDICAL CHRONICLE

Challenges include: • Early detection • The time delay before the diagnosis can be made • To differentiate from other psychotic disorders • The stigma attached to the disorder • Life long illness • No biomarker

• Fairly rare disorder.

Can schizophrenia be diagnosed in the prodromal phase?

PRODROMAL SYMPTOMS The following are prodromal phase symptoms: • Marked social isolation or withdrawal • Marked impairment in role functioning • Markedly peculiar behaviour • Marked impairment in personal hygiene and grooming • Blunted or inappropriate affect • Digressive, vague, over-elaborate or circumstantial speech, or poverty of speech, or poverty of content of speech • Odd beliefs or magical thinking • Unusual perceptual experiences • Marked lack of initiative, interests or energy.

NEURODEVELOPMENTAL Neurodevelopmental hypotheses show major structural brain abnormalities relating to: • Cingulum • External capsule • Fornix • Corona radiata • Thalamic radiation • Body and genu of the corpus callosum • Superior fronto-occipital fasciculus • Superior longitudinal fasciculus • Uncinate fasciculus.

DRUG-INDUCED SCHIZOPHRENIA Drug-induced schizophrenia shows a correlation with the use of cannabis. Six genes have been identified that give a much higher chance of developing schizophrenia with the use of cannabis.

GENETIC STUDIES This is a multifactorial disease in terms of genetics. Genetic studies are still inconclusive.

PSYCHOMETRIC TESTING • Rorschach test may indicate a more psychotic than depressive process • WAISS/SSAIS-R. VIRAL HYPOTHESIS Growing evidence that viruses and inflammation play a part in the aetiology of schizophrenia. Inflammation and viral infections have also been shown to play a role, with more patients being born in the winter months being diagnosed with schizophrenia. There is a higher incidence of schizophrenia after pandemics. We have seen with Covid-19 that there is a neuronal aspect.

OBSTACLES Obstacles in the treatment of schizophrenia include: • How is remission defined? We don’t have a standard global definition • Medication doesn’t offer a cure • Medication has several side effects, such as metabolic and neurological.

TREATMENT Early intervention is possible and critical, after the first psychotic episode. Prevent any further relapses. You should treat patients as you would treat patients with myocardial infarctions, to give you an idea of severity. The aim is to prevent another attack at all costs. Do all that you can to ensure compliance, especially in the early phases of the disease.

Other therapy areas, such as multiple sclerosis, also advocate early intervention in order to prevent further decline in patient functioning. In the natural course of schizophrenia, each relapse is linked to brain tissue loss and functional decline.

Relapse is the rule rather than the exception for people living with schizophrenia without effective treatment.

Discontinuation of antipsychotic medication shows a one-year recurrence rate of 77% and at two years, the risk of recurrence >90%. Continuation of antipsychotic medication has one-year recurrence rate of only 3%.

TREATMENT Treatment involves medication, psychotherapy and electroconvulsive therapy (reserved for patients who don’t react quickly to medication).

Medication is divided into longacting injectable antipsychotics and oral antipsychotics. In terms of mortality risk reduction, any antipsychotic is better than no treatment at all.

Therapy includes psychotherapy such as family interventions or cognitive behavioural therapy, and occupational therapy, being cognitive rehabilitation and work hardening.

7 COGNITIVE DOMAINS TESTED IN SCHIZOPHRENIA 1. Speed of processing 2. Attention/ vigilance 3. Working memory 4. Verbal learning and memory 5. Visual learning and memory 6. Reasoning and problem solving 7. Social cognition.

KEY POINTS • The first six months of treatment is crucial • Ensure compliance • Treat schizophrenia as a metabolic illness.

WEBINAR REPORT

A discussion on

connective tissue disease Dr Ajesh Maharaj, consultant physician/ consultant rheumatologist at Life Westville Hospital in KwaZulu-Natal recently presented an informative webinar on connective tissue disease. This was sponsored by Thermo Fisher Scientific and hosted by Medical Chronicle. The following article is based on his presentation.

D

R AJESH FOCUSSED on the following in his presentation: • Understand the classification criteria of systemic lupus erythematosus (SLE) • Clinical features • Assessment • Latest treatment approaches.

SYSTEMIC LUPUS ERYTHEMATOSUS: 1982 CLASSIFICATION CRITERIA If we look at the systemic lupus erythematosus: 1982 classification criteria definitions, we see 11 criteria: • Malar rash. Fixed erythema, flat or raised, sparing the nasolabial folds • Discoid rash. Raised patches, adherent keratotic scaling, follicular plugging; older lesions may cause scarring • Photosensitivity. Skin rash from sunlight • Oral or nasopharyngeal ulcers, usually painless • Arthritis. Nonerosive, inflammatory in two or more peripheral joints • Serositis. Pleuritis or pericarditis.

• Renal disorder. Persistent proteinuria or cellular casts • Neurologic disorder. Seizures or psychosis • Hematologic haemolytic anaemia, leukopenia (<4 000/mm3), lymphopenia (<1 500/mm³), or thrombocytopenia (<100 00/mm3) • Immunologic disorder. Antibodies to double-stranded deoxyribonucleic acid (dsDNA) or SM or positive antiphospholipid antibodies (IgG or IgM antibodies, lupus anticoagulant, or falsepositive serologic test positive serologic test for syphilis) • Antinuclear antibody test: Positive.

The Systemic Lupus International Collaborating Clinics (SLICC) classification had 17 criteria. According to the SLICC rule for the classification of SLE, the patient must satisfy at least four criteria.

CLASSIFICATION OF NEPHRITIS Systemic lupus erythematosus: classification of nephritis • Normal glomeruli • a) Nil by all techniques • b) Normal by light but deposits on electron microscopy or immunofluorescence • Mesangial glomerulonephritis • Focal glomerulonephritis • Diffuse glomerulonephritis (this is the worst type) • Diffuse membranous glomerulonephritis • Advanced sclerosing glomerulonephritis.

Systemic lupus erythematosus: nervous

system manifestations: • Seizures • Ataxia • Headache • Rigidity, tremor • Stroke syndromes • Chorea • Subarachnoid haemorrhage • Hemiballismus • Transverse myelitis • Coma • Multiple sclerosis-like disorder • Dementia • Optic neuritis • Psychiatric disorders • Aseptic meningitis • Peripheral neuropathy • Cranial neuropathy • Mononeuritis multiplex • Guillain-Barré syndrome.

If antinuclear factor ANF tests positive, please request extractable nuclear antigen antibodies (ENAs) panel.

DRUG-INDUCED LUPUS Definite drug associations are: • Hydralazine • Procainamide • Minocycline • Chlorpromazine • Isoniazid • Penicillamine • Methyldopa • Interferon-alpha.

Possible drug associations include: • Anticonvulsants • Quinidine • Propylthiouracil • Sulfonamides • Lithium • Beta-blockers • Nitrofurantoin • Sulfasalazine.

Clinicians ordering the anti-nuclear antibodies (ANA) test should be aware of the test's low-positive predictive value in settings with a low prevalence of rheumatic disease, particularly among older patients.

BASELINE INVESTIGATIONS FOR SLE • Full blood count • Urea and electrolytes • Complement (C3 & C4) test • ANF with ENAs/ dsDNA/ anti Smith Antibodies • Antiphospholipid antibodies/ Anticardiolipin antibodies • Lupus anticoagulant • Urine for microscopy and sensitivity/

Dr Ajesh Maharaj MB.BS; (India); H.Dip.Int.Med.(SA); FCP(SA); Cert in Rheumatology(SA); FACR; Ph.D. (Universiteit van Amsterdam)

To watch a replay of the webinar and still earn your CPD point, go to https://bit.ly/3kW6tMe

urinary creatinine: protein ration • 24-hour urinary protein with creatinine clearance.

• Constitutional symptoms • Rash: body surface area (BSA) <9% • Platelets; 50-100 x 109/L.

PRELIMINARY CLASSIFICATION CRITERIA FOR ANTIPHOSPHOLIPID SYNDROME • APS is present if more than one clinical and one lab criteria met • Vascular thrombosis • > One arterial, venous, or small-vessel thrombosis and • Thrombosis confirmed by imaging or Doppler or histopathology and • Without evidence of inflammation in vessel wall on histpathologic confirmation • Pregnancy morbidity • > One foetal death > 10th week gestation or • > One premature birth > 34th week with preeclampsia or placental insufficiency or • > Three consecutive spontaneous abortions • < 10th week gestation • Laboratory criteria • Anticardiolipin antibody IgG or IgM present medium or high titers >two times at least six weeks apart or • Lupus anticoagulant present > two times at least six weeks apart.

Moderate disease: • Rheumatoid arthritis like arthritis • Rash: 9%-18% BSA • Cutaneous vasculitis <18% BSA • Platelets; 20-50x 109/L • Serositis.

ANTIPHOSPHOLIPID ANTIBODY SYNDROME Clinical manifestations of this include: • Arterial thrombosis • Venous thrombosis • Valvular abnormalities • Pregnancy loss and infertility • Livedo reticularis • Cerebrovascular thrombosis • Chorea.

Antiphospholipid antibody syndrome: tests • Partial thromboplastin time (PTT) • Lupus anticoagulant • Anticardiolipin antibodies by ELISA • Anti-B2-glycoprotein one antibody • False-positive biologic test for syphilis • Russell viper venom test • Platelet count • Antinuclear and anti-DNA antibodies.

Ancillary investigations • Chest x-ray • Electrocardiogram.

Assessment of SLE Mild disease:

SEVERE DISEASE • Major organ threatening disease: nephritis, cerebritis, myelitis, pneumonitis, mesenteric vasculitis • Severe thrombocytopenia with platelets <20 x 109/L • Thrombotic thrombocytopenic purpuralike disease • Acute haemophagocytic syndrome.

TREATMENT OF NON-RENAL SLE Generally, chloroquine is accepted as treatment for all forms of mild, moderate, or severe disease. You can use systemic steroids such as glucocorticoids and prednisone, and we generally use a combination of chloroquine and prednisone.

Prednisone is generally started at 1mg per kilogram depending on what the severity of the disease is, especially if they have kidney involvement, brain involvement, lung involvement or heart involvement, it’s generally pulse glucocorticoids systemic corticosteroids and then once we get them under control, we can use methotrexate as a steroid-sparing agent.

In patients with moderate to severe disease we use belimumab, which is not available in South Africa, but it is available on Section 21 if it is needed in patients.

We don’t have calcineurin inhibitors, but we have mycophenolate mofetil, which we can use for moderate to severe disease.

In patients with severe lupus, we can use cyclophosphamide generally administered as a pulse cyclophosphamide, as a monthly dose and if everything else fails in a patient with lupus after having put them on chloroquine, prednisone, azathioprine, methotrexate, mycophenolate mofetil and cyclophosphamide we then use rituximab which is a biologic for the treatment of lupus and is registered in South Africa for the treatment of systemic lupus erythematosus. This is generally reserved as a last treatment option, and it is done by a rheumatologist.

MEDICAL CHRONICLE | May 2022 37

OPINION

How does motivational interviewing improve patient adherence?

Healthcare practitioners often face the challenge of helping people change long-standing behaviours that pose significant health risks.

W

HEN PATIENTS RECEIVE compelling advice to adopt a healthcare lifestyle by cutting back or ceasing harmful behaviours (smoking, overeating and heavy drinking) or adopting healthy or safe behaviours (taking medication as prescribed, eating more fruit and vegetables and exercising) it can be frustrating and bewildering when this advice is ignored or contested.

A natural response for a practitioner who encounters such ‘resistance’ is to re-iterate the health advice with greater authority or to adopt a more coercive style to educate the patient about the imminent health risks if they do not change.

When these strategies don’t succeed, the practitioner may characterise the patient as unmotivated or lacking insight.

Motivation is a dynamic state that can fluctuate depending on the practitioner's style. Authoritative or paternalistic therapies can increase resistance to change.

Motivational interviewing (MI) is an important part of health professional patient communication and has a positive effect on both the patient and healthcare providers. An important component to health-related behaviour change, centres around motivation, ambivalence and resistance. Ambivalence is a conflicted state where opposing attitudes or feelings co-exist in an individual. They are ‘stuck’ between simultaneously wanting to change and not wanting to change.

Ambivalence is particularly evident in situations where there is a conflict between an immediate reward and long-term adverse consequences (substance abuse, weight management or exercise programmes).

The patient presents with a serious health problem and shows genuine concern about the impact of the condition on their health, but despite recommendations from the practitioner to cut back on toxic substances or unacceptable activities, they continue to adhere to the harmful activity.

‘The definition and implementation of MI grew out of the 'Prochaska and DiClemente model and Miller and Rollnicks’ work in the field of addiction and medicine which outlined three critical components of motivation: 1. The importance of change for a patient (willingness) 2. The confidence of change (ability)

38 May 2022 | MEDICAL CHRONICLE

3. Whether change is an immediate priority (readiness).

treatment and their dilemmas as they currently view them.

Using MI techniques, the practitioner can tailor motivational strategies to the individual’s stage and readiness to change.

MI is a counselling method that involves enhancing a patient’s motivation to change by four guiding principles, represented by the acronym RULE: Resist the rightening reflex; Understand the patient’s own motivation; Listen with empathy and empower the patient.

Patients become motivated to take up new health behaviours due to the awareness and responsibility for their health condition, which translates into better treatment outcomes and higher disease prevention that health professionals can be proud of.

For the provider of care, MI constitutes a good form of communication that provides self-confidence, professionalism and protects against burn-out.

2. Focusing Once the client is more engaged in the process of overcoming the medical condition, the counsellor guides them towards a specific goal. This goal is determined by the client. However, the focus is a behaviour or circumstance the client picks, wishes to understand better and to overcome.

STAGES OF CHANGE MODEL AND MI Prochaska and DiClemente proposed a behaviour change process modelled in five parts. This outlines a progress from initial precontemplation stage, where an individual is not considering change to a contemplative stage where the individual is activity ambivalent about change, to preparation where an individual begins to plan and commit change.

It was also proposed that readiness for change as a vital mediator of behavioural change. Prochaska and DiClemente transtheoretical model of behavioural change (the stages of change) describes readiness as a dynamic process, in which the pros and cons of change generate ambivalence. Such progress through these changes leads to action, where necessary steps to achieve change are undertaken.

If successful the action leads to the final stage, maintenance, where the person works to maintain and sustain long-term change.

THE FOUR GENERAL PROCESSES OF MI 1. Engaging The counsellor works to understand the client’s perspective, with empathy and without outside judgement or agenda. This is an important step towards understanding why the client is ambivalent about

3. Evoking Based on the client’s choice of focus, the counsellor or therapist will help them evoke reasons for the chosen focus. The therapist will listen and recognise changes in the way the client speaks, which may lead into the client soliciting advise, however the therapist role, in this situation, is not to give advice unless requested.

4. Planning This step involves taking the language the client used to evoke their desire to change a specific behaviour or situation and turning it into action. Depending entirely on the client, the planning stage could involve journaling, making a list or working with the therapist to be held responsible for actions.

Motivational Interviewing is ultimately a process that can be transformed to fit each individual client that a therapist works with.

While the first three stages are considered defining characteristics of motivational interviewing, the final stage – planning – is not a required step until the client is ready.

THE SPIRIT OF MI The spirit of MI is based on three key elements: - Collaboration – between therapist and client. It is essentially a partnership between the therapist and the client grounded in the point of view and experience of the client.

- Evoking or drawing out – The client’s ideas about change. It builds rapport and facilitates trust in helping relationships which can be challenging in a more hierarchical relationship.

- Autonomy of the client.

MI approach is one of the therapists drawing out the individual’s own thoughts and ideas rather than imposing their opinions. Unlike

Prof Morgan Chetty, Visiting Prof: Health Sciences, DUT chairman, IPAF, CEO: KZNDHC

other treatment models that emphasise the clinicians as an authority figure, MI recognises that the true power of change rests within the client.

This process empowers the individual and gives responsibility to the client for their own action. There is no single right way to change and that there are multiple ways that change can occur. The client must take the lead in developing a ‘menu of opinions’ as to how to achieve the desired change.

A TECHNIQUE TO OVERCOME RESISTANCE From MI perspective, resistance in treatment occurs when the client experiences a conflict between their view of the problem or the solution, and that of the clinician or when the client experiences their freedom or autonomy being infringed upon.

These experiences are often the basis of the client’s ambivalence about change.

In MI, one avoids eliciting resistance by not confronting the client when resistance occurs, but they work to de-escalate and avoid a negative interaction. Instead employ a technique called ‘Rolling with It’. Accept the client’s views to address the solution together, led by the client.

By Rolling with Resistance, it disrupts any struggle that may occur, and the session does not resemble an argument or the client’s playing devil’s advocate or responding, “Yes, but …” to the counsellor’s suggestion. Clients need to define the problem and develop their own solution, leaves little for the client to resist. A frequently used metaphor is dancing rather than wrestling with the client.

MI SKILLS AND STRATEGIES Change talk involves statements or nonverbal communication, indicating that the client may be considering the possibility of change. A basic approach used in MI is described by the pneumonic OARS: - Open-ended questions -A ffirmation (statements that recognise the patient’s strengths) -R eflection (careful listening and reflective responses) - Summaries.

This allows the process of MI to move forward by establishing a therapeutic alliance and eliciting discussion about change.

PLACEBO

MEDChronicle © Copyright Medical Chronicle 2022

EDITORIAL EDITOR: Claire Rush McMillan Claire.Rush@newmedia.co.za NEWS WRITER: Nicky Belseck Nicky.Belseck@newmedia.co.za SUB-EDITOR: Gill Abrahams EDITORIAL CONTRIBUTORS Dr Ilhaam Mohamed, Prof James Ker, Dr Justus Apffelstaedt, Prof Morgan Chetty LAYOUT & DESIGN: Naresh Budraj ADVERTISING ADVERTISING EXECUTIVES Anel du Plooy - Tel: 082 786 9517 Anel.duPlooy@newmedia.co.za Cindy Riederer - Tel: 082 492 0229 Cindy.Riederer@newmedia.co.za

Beat the odds in severe brain injury

Early intervention in paediatric brain complications is key to improved development in later years.

A

LITTLE GIRL WHO astonished healthcare professionals with her remarkable progress following a severe brain injury has, one year later, become a shining example of just what a difference rehabilitation can make to the developing brain.

Three-year-old Nhlelo Chauke was travelling home from a family visit in Limpopo in January last year when her mother’s vehicle was involved in a terrible car accident that left Nhlelo totally unresponsive, with paramedics having to resuscitate her at the scene. After three weeks spent fighting for her life at Netcare Montana Hospital, Nhlelo was transferred to Netcare Rehabilitation Hospital in Johannesburg.

According to Prof Andre Mochan, neurologist practising at the paediatric unit of the rehabilitation facility, it was clear that Nhlelo had a long way to go in regaining brain functionality. “She had suffered a diffuse brain injury, where due to the impact of the accident the nerves and cells had been badly shaken, resulting in bleeding in multiple parts of the brain. On arrival, she was completely non-communicative, had difficulty responding to visual stimuli and her movements were totally uncoordinated.

She was not able to sit up or hold up her head.” Prof Mochan, along with the other members of the dedicated multi-disciplinary paediatric team in the unit, spent the first three days

assessing Nhlelo using internationally recognised scoring systems. “Nhlelo’s scores were very low but there were some hopeful signs, such as her ability to move her limbs and open her eyes,” says Prof Mochan. Charne Cox, Nhlelo’s physiotherapist at the rehabilitation hospital, explains that although she was three years old, Nhlelo’s brain injury was so severe that the team needed to go right back to the basics of baby movements – doing tummy time, learning to roll, learning to sit and so on.

“As therapists, we almost always work together through all treatments, so that our patients have the benefit of not only therapies by a multi-disciplinary team but also interdisciplinary involvement.” Cox explains that many different types of therapy were involved in Nhlelo’s treatment, such as the use of a tilt table to familiarise her with the sensation of standing once more. Neural optometrists from Eyetek, who assist in all cases involving visual concerns, did visual stimulation exercises in the darkroom to strengthen her eye muscles.

“Our speech therapist worked on imitating gestures to encourage Nhlelo to communicate, such as waving, reaching, smiling and so on. Within the first week, we began to see improvements in her scores and as she progressed she became increasingly engaged and enthusiastic. “Nhlelo really enjoyed the hydrotherapy in the heated pool where

we have floating toys. This is always a joyful experience for children as the weightlessness in the water gives them a great sense of freedom. She also loved the visits to the hospital by TOP Dogs – these are clean, highly trained therapy dogs. Patients can brush, feed and, if possible, walk them. Nhlelo also enjoyed the baking groups which provide a sense of community fun and cognitive stimulation.

While Nhlelo’s progress was far beyond our expectations, we find that all children have amazing mental strength and can adapt more quickly and easily than an adult, provided they have the appropriate support,” notes Cox. Nhlelo was discharged in April 2021 and now, one year later, her father says he sees her recovery as a miracle. “She attends creche every day and while she still has some difficulties with her balance due to an ongoing issue with her ear, she is improving all the time. She’s very smart and loves counting, reciting the days of the week and the months of the year, and is fascinated by colour.

Prof Mochan further points out that when it comes to children’s brains the rehabilitation process is particularly complex compared to that of the adult brain, which is already fully developed. In a child, injury disturbs normal development, which needs to be addressed in addition to the recovery from the injury itself.

MEDICAL CHRONICLE | May 2022 39

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